Are progressive shoulder exercises feasible in patients with glenohumeral osteoarthritis or rotator cuff tear arthropathy?

BACKGROUND: Little is known about the feasibility of progressive shoulder exercises (PSE) for patients with glenohumeral osteoarthritis (OA) or rotator cuff tear arthropathy (CTA). The aim of this study was to investigate whether 12 weeks of PSE is feasible in patients with glenohumeral OA or CTA eligible for shoulder arthroplasty. Moreover, to report changes in shoulder function and range of motion (ROM) following the exercise program. METHODS: Twenty patients were included. Eighteen patients (11 women, 15 with OA), mean age 70 years (range 57-80), performed 12 weeks of PSE with one weekly physiotherapist-supervised and two weekly home-based sessions. Feasibility was measured by dropout rate, adverse events, pain, and adherence to PSE. At baseline and end of intervention, patients completed the Western Ontario Osteoarthritis of the Shoulder (WOOS) score and Disabilities of the Arm, Shoulder and Hand (DASH). Data to assess feasibility were analyzed using descriptive statistics. RESULTS: Two patients dropped out and no adverse events were observed. Sixteen of the eighteen patients (89%) had a high adherence (≥ 70%) to the physiotherapist-supervised sessions. Acceptable pain levels were reported; in 76% of all exercise sessions with no numeric rating scale (NRS) score over five for any exercise. WOOS improved with a mean of 23 points (95% CI 13;33), and DASH improved with a mean of 13 points (95% CI 6;19). CONCLUSION: Adherence to PSE was high and dropout rates were low. PSE is feasible, safe and may relieve shoulder pain, improve function and ROM in patients with glenohumeral OA or CTA. The patient-experienced gains after PSE seem clinically relevant and should be compared to arthroplasty surgery in a RCT setting. TRIAL REGISTRATION: According to Danish law, this study did not need an approval by the Central Denmark Region Committee on Health Research Ethics. Approval from The Danish Data Protection Agency (journal number 1-16-02-15-20) was obtained.

The influence of exercise on clinical pain and pain mechanisms in patients with subacromial pain syndrome.

BACKGROUND: Few studies have investigated the underlying mechanisms for unilateral subacromial pain syndrome (SAPS). Therefore, this study examined (1) if 8-weeks of exercise could modulate clinical pain or temporal summation of pain (TSP), conditioned pain modulation (CPM), and exercise-induced hypoalgesia (EIH) and (2) if any of these parameters could predict the effect of 8-weeks of exercise in patients with unilateral SAPS. METHODS: Thirty-seven patients completed a progressive abduction exercise program every other day for 8-weeks. Worst shoulder pain in full abduction was rated on a numeric rating scale (NRS). Pain pressure thresholds (PPTs), TSP, CPM, EIH, Shoulder Pain and Disability Index (SPADI), Pain Catastrophizing Scale (PCS), PainDETECT questionnaire (PD-Q), Pain Self-Efficacy Questionnaire (PSE-Q) and Pittsburgh Sleep Quality Index (PSQI) were assessed before and after intervention. RESULTS: The intervention improved worst pain intensity (p < 0.001), increased the CPM (p < 0.001), improved the sleep scores (p < 0.005) and reduced the PainDETECT ratings (p < 0.001). No changes were observed in PPT, TSP, EIH, SPADI, PCS and PSE-Q (all p > 0.05). In a linear regression, the combination of all baseline parameters predicted 23.2% variance in absolute change in pain after 8 weeks. Applying backwards elimination to the linear regression yielded that baseline pain intensity combined with TSP predicted 33.8% variance. CONCLUSION: This explorative study suggested reduction in pain, improved sleep quality and increased CPM after 8-weeks of exercise. Furthermore, the results suggests that low pain intensity and high TSP scores (indicative for pain sensitisation) may predict a lack of pain improvement after exercise.

High Completeness and Accurate Reporting of Key Variables Make Data from the Danish Shoulder Arthroplasty Registry a Valuable Source of Information.

PURPOSE: The Danish Shoulder Arthroplasty Registry (DSR) is a nationwide database providing data for research and health care monitoring. The aim of this study was to validate the DSR by (1) assessing registration completeness, (2) comparing key variables with information from medical records, (3) assessing the number and proportion of missing data for key variables. MATERIALS AND METHODS: The completeness of registration in the DSR from 2006-2015 was assessed for primary arthroplasties by comparing the number of arthroplasties reported to the DSR with the number of arthroplasties recorded by the Danish National Patient Register which is an administrative database used by the Danish healthcare authorities to monitor all hospitalizations including shoulder arthroplasty surgery. Positive predictive values (PPV) were used to estimate the accuracy of the reporting in a randomly selected population. Information retrieved from medical records were used as gold standard. The number of missing values for each variable was evaluated to depict if these registrations were missing at random. RESULTS: The completeness of reporting was 94.4. The PPV for the three major indications: osteoarthritis, fracture and rotator cuff arthropathy was 92%, 97%, and 94%, respectively. PPV was high for resurfacing arthroplasty (93%) and reverse shoulder arthroplasty (93%), but low for total shoulder arthroplasty (79%) and hemiarthroplasty (83%). The proportion of missing data in DSR was less than 1% for age, gender, previous surgery, indication and arthroplasty type and these can be regarded as missing at random. CONCLUSION: The study showed that data from the DSR are sufficiently valid to be used for research and quality monitoring. Lower PPV's for total shoulder arthroplasty and hemiarthroplasty are possibly related to inadequate definitions and mutually nonexclusive items in the reporting form. Regular validation is necessary since the data reported to the registry continuously evolve because of changes in clinical practice.

Low arthroplasty survival after treatment for proximal humerus fracture sequelae: 3,245 shoulder replacements from the Nordic Arthroplasty Register Association.

Background and purpose - Proximal humerus fractures (PHF) may result in sequelae indicating arthroplasty. We report cumulative survival rates and reasons for revision after arthroplasty for proximal humerus fracture sequelae (PHFS).Patients and methods - Data were derived from the Nordic Arthroplasty Register Association. The Kaplan-Meier method was used to illustrate survival rates. A scaled Schoenfeld residual plot was used to report the risk of revision for men relative to women in patients who were treated with reverse shoulder arthroplasty (RSA). Revision was defined as removal or exchange of any component or the addition of a glenoid component.Results - 30,190 primary arthroplasties were reported from 2004 to 2016, of which 3,245 were for PHFS. The estimated 1-, 5-, and 10-year cumulative survival rates (95% CI) were 96% (95-97), 90% (89-92), and 86% (83-88) for stemmed hemiarthroplasty and 94% (92-95), 89% (87-91), and 86% (82-90) for RSA with a median time to revision of 18 months (IQR 9-44) and 3 months (IQR 0-17). The risk of revision for men relative to women in patients who were treated with RSA was 3.2 (1.9-5.1) 0-1 year after surgery and 1.9 (0.9-4.1) 1-8 years after surgery. The estimated 1-, 5-, and 10-year cumulative survival rates (95% CI) were 94% (92-96), 88% (85-90), and 80% (75-86) for men and 95% (94-96), 86% (84-89), and 81% (77-84) for young patients.Interpretation - Shoulder arthroplasty for PHFS was associated with lower survival rates, compared with previously published results of shoulder arthroplasty for acute PHF. The low arthroplasty survival rates for men and young patients especially are worrying.

Can Machine-learning Algorithms Predict Early Revision TKA in the Danish Knee Arthroplasty Registry?

BACKGROUND: Revision TKA is a serious adverse event with substantial consequences for the patient. As the demand for TKA rises, reducing the risk of revision TKA is becoming increasingly important. Predictive tools based on machine-learning algorithms could reform clinical practice. Few attempts have been made to combine machine-learning algorithms with data from nationwide arthroplasty registries and, to the authors' knowledge, none have tried to predict the likelihood of early revision TKA. QUESTION/PURPOSES: We used the Danish Knee Arthroplasty Registry to build models to predict the likelihood of revision TKA within 2 years of primary TKA and asked: (1) Which preoperative factors were the most important features behind these models' predictions of revision? (2) Can a clinically meaningful model be built on the preoperative factors included in the Danish Knee Arthroplasty Registry? METHODS: The Danish Knee Arthroplasty Registry collects patients' characteristics and surgical information from all arthroplasties conducted in Denmark and thus provides a large nationwide cohort of patients undergoing TKA. As training dataset, we retrieved all preoperative variables of 25,104 primary TKAs from 2012 to 2015. The same variables were retrieved from 6170 TKAs conducted in 2016, which were used as a hold-out year for temporal external validation. If a patient received bilateral TKA, only the first knee to receive surgery was included. All patients were followed for 2 years, with removal, exchange, or addition of an implant defined as TKA revision. We created four different predictive models to find the best performing model, including a regression-based model using logistic regression with least shrinkage and selection operator (LASSO), two classification tree models (random forest and gradient boosting model) and a supervised neural network. For comparison, we created a noninformative model predicting that all observations were unrevised. The four machine learning models were trained using 10-fold cross-validation on the training dataset after adjusting for the low percentage of revisions by over-sampling revised observations and undersampling unrevised observations. In the validation dataset, the models' performance was evaluated and compared by density plot, calibration plot, accuracy, Brier score, receiver operator characteristic (ROC) curve and area under the curve (AUC). The density plot depicts the distribution of probabilities and the calibration plot graphically depicts whether the predicted probability resembled the observed probability. The accuracy indicates how often the models' predictions were correct and the Brier score is the mean distance from the predicted probability to the observed outcome. The ROC curve is a graphical output of the models' sensitivity and specificity from which the AUC is calculated. The AUC can be interpreted as the likelihood that a model correctly classified an observation and thus, a priori, an AUC of 0.7 was chosen as threshold for a clinically meaningful model. RESULTS: Based the model training, age, postfracture osteoarthritis and weight were deemed as important preoperative factors within the machine learning models. During validation, the models' performance was not different from the noninformative models, and with AUCs ranging from 0.57 to 0.60, no models reached the predetermined AUC threshold for a clinical useful discriminative capacity. CONCLUSION: Although several well-known presurgical risk factors for revision were coupled with four different machine learning methods, we could not develop a clinically useful model capable of predicting early TKA revisions in the Danish Knee Arthroplasty Registry based on preoperative data. CLINICAL RELEVANCE: The inability to predict early TKA revision highlights that predicting revision based on preoperative information alone is difficult. Future models might benefit from including medical comorbidities and an anonymous surgeon identifier variable or may attempt to build a postoperative predictive model including intra- and postoperative factors as these may have a stronger association with early TKA revisions.

Low risk of revision after reverse shoulder arthroplasty for acute proximal humeral fractures.

BACKGROUND: Reverse shoulder arthroplasty (RSA) has gained popularity in the treatment of proximal humeral fractures (PHFs), especially in elderly patients. The purpose of this study was to investigate the use of RSA implants for acute PHFs and risk of revision, as well as risk factors for revision. METHODS: RSA implants for acute PHFs were identified from the Nordic Arthroplasty Register Association registry data from 2004 to 2016. Kaplan-Meier survival analysis was used to calculate implant survival. Cox multiple regression analysis was used to calculate the adjusted revision rate for sex, age, country of operation, and year of surgery. RESULTS: The study included 1523 RSA implants for PHFs (84% women; average age, 77 years; average follow-up time, 2.5 years). The 5-year cumulative implant survival rate was 97% (confidence limits, 95.5% and 98%). Revision was performed for 33 implants (2%). The most common reason for revision was instability, occurring in 11 cases (0.7%), followed by fracture, occurring in 6 (0.4%), and infection, occurring in 5 (0.3%). Four different arthroplasty brands were used in this cohort, with the Delta Xtend in two-thirds of cases (n = 1025). Age younger than 60 years and male sex were associated with slightly higher rates of revision; however, these differences did not reach statistical significance (hazard ratio of 2.02 with P = .075 and hazard ratio of 3.23 with P = .057, respectively). CONCLUSION: The use of RSA for acute PHFs is increasing in the Nordic countries. The short-term risk of revision is low. The main reason for revision of RSA for this indication is instability.

Neuromuscular Exercises Improve Shoulder Function More Than Standard Care Exercises in Patients With a Traumatic Anterior Shoulder Dislocation: A Randomized Controlled Trial.

BACKGROUND: There is an important gap in knowledge about the effectiveness of nonoperative treatment (exercise) for patients with traumatic primary and recurrent anterior shoulder dislocations (ASDs). PURPOSE/HYPOTHESIS: The purpose of this study was to assess the efficacy and safety of physical therapist-supervised, shoulder instability neuromuscular exercise (SINEX) versus self-managed, home-based, standard care shoulder exercise (HOMEX) in patients with traumatic ASDs. The hypothesis was that SINEX would have a larger effect and fewer adverse events compared with HOMEX. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: A total of 56 participants with radiographically verified, trauma-initiated primary or recurrent ASDs and self-reported decreased shoulder function were randomized to 12 weeks of either SINEX or HOMEX. The SINEX program consisted of 7 exercises, individually progressing from basic (2 × 20 repetitions each day) to elite (2 × 10 repetitions, 3 times weekly). The HOMEX program included 5 shoulder exercises performed 3 times weekly (2 × 10 repetitions). The primary outcome was the Western Ontario Shoulder Instability Index (WOSI) score, ranging from 0 (best possible) to 2100. The between-group minimal clinically important difference at 12 weeks was 250 points. Secondary outcomes included WOSI subdomain scores, patient-reported ratings of kinesiophobia and pain, objective shoulder function, patient satisfaction, and number of adverse events. RESULTS: The between-group mean difference in the WOSI total score at 12 weeks significantly favored SINEX over HOMEX (-228.1 [95% CI, -430.5 to -25.6]). SINEX was furthermore superior to HOMEX in most of the secondary outcomes (3/4 subdomains of the WOSI and pain level during the past 7 days as well as clinical signs of anterior shoulder instability). Also, although not statistically significant, less than half the proportion of the SINEX patients compared with the HOMEX patients (3/27 [11%] vs 6/24 [25%], respectively; P = .204) underwent or were referred for shoulder stabilizing surgery. Satisfaction with both exercise programs was high, and no serious adverse events were reported. CONCLUSION: Neuromuscular shoulder exercise (SINEX) was superior to standard care exercise (HOMEX) in patients with traumatic ASDs. Further long-term follow-ups on treatment effects are needed. REGISTRATION: NCT02371928 (ClinicalTrials.gov identifier).

Revision Risk for Total Knee Arthroplasty Converted from Medial Unicompartmental Knee Arthroplasty: Comparison with Primary and Revision Arthroplasties, Based on Mid-Term Results from the Danish Knee Arthroplasty Registry.

BACKGROUND: Medial unicompartmental knee arthroplasties (UKAs) have good clinical outcomes but implant survival is inferior to that of total knee arthroplasties (TKAs). Conversion to a TKA is a reliable option when UKA fails. However, there is controversy regarding these conversions. The aim of this study was to analyze the survival of TKAs converted from UKAs when compared with both primary and revision TKAs. METHODS: On the basis of registrations in the Danish Knee Arthroplasty Registry from 1997 to 2017, 1,012 TKAs converted from UKAs were compared with 73,819 primary TKAs and 2,572 revision TKAs. The primary outcome was the risk of revision. Secondarily, the study analyzed the influence of different implants, the indication for the UKA conversion, and surgical volume on the survival of TKA converted from UKA. Third, the study compared the indications for revision. RESULTS: The converted UKAs were mainly mobile-bearing (85%) and, at the time of conversion, the patients were younger (mean [standard deviation], 66 ± 10 years) and more were Charnley class A (55%) compared with patients with primary TKA (70 ± 9 years and 35% class A) or revision TKA (70 ± 10 years and 42% class A) (all p < 0.001). The survival of TKAs converted from UKAs was comparable with that of revision TKAs (p = 0.42) and significantly inferior to the survival of primary TKAs (p < 0.001). This relationship was unaffected by differences between the groups, with an adjusted hazard ratio of 0.94 (95% confidence interval [CI]: 0.74 to 1.19) compared with revision TKAs and 3.00 (95% CI: 2.47 to 3.66) compared with primary TKAs. The survival of TKA converted from UKA was unaffected by differences in the conversion implants (all p ≥ 0.47), experience with revision surgery (all p ≥ 0.06), and the indications for the UKA-to-TKA conversion (all p ≥ 0.27). Instability (26%) and unexplained pain (13%) were more frequent indications for revisions of TKA converted from UKA (p < 0.001). CONCLUSIONS: TKA converted from medial UKA has a 3-fold higher risk of revision when compared with primary TKA. The implant survival resembled that of revision TKA but with a higher prevalence of unexplained pain and instability. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Patients with non-operated traumatic primary or recurrent anterior shoulder dislocation have equally poor self-reported and measured shoulder function: a cross-sectional study.

BACKGROUND: Patients with non-operated traumatic primary anterior shoulder dislocation (PASD) are assumed to have less shoulder impairment than patients with recurrent anterior shoulder dislocations (RASD). This may impact treatment decision strategy. The aim was to study whether patients with non-operated traumatic PASD have less shoulder impairment than those with RASD. METHODS: In a cross-sectional study baseline data from patients with PASD and RASD in a randomised controlled trial of non-operative shoulder exercise treatment were used. Shoulder function was self-reported (Western Ontario Shoulder Instability (WOSI), Tampa Scale of Kinesiophobia (TSK), General Health (EQ-5D-VAS), Numeric Pain Rating Scale (NPRS)), and measured (Constant-Murley shoulder Score (CMS total), CMS - Range of Motion (CMS-ROM, CMS - strength, proprioception, clinical tests). RESULTS: In total, 56 patients (34 (28 men) with PASD and 22 (21 men) with RASD) (mean age 26 years) participated. WOSI total was 1064 and 1048, and TSK above 37 (indicating high re-injury fear) was present in 33 (97%) and 21 (96%) of the groups with PASD and RASD, with no group difference. CMS total (66.4 and 70.4), CMS-ROM (28.7 and 31.5), CMS-strength (injured shoulder: 7.6 kg and 9.1 kg), proprioception and clinical tests were the same. Furthermore, 26 (76%) with PASD and 13 (59%) with RASD reported not to have received non-operative shoulder treatment. CONCLUSIONS: Non-operated patients with PASD and self-reported shoulder trouble three-six weeks after initial injury do not have less shoulder impairment (self-reportedly or objectively measured) than non-operated patients RASD and self-reported shoulder trouble three-six weeks after their latest shoulder dislocation event.

Risk and risk factors for revision after primary reverse shoulder arthroplasty for cuff tear arthropathy and osteoarthritis: a Nordic Arthroplasty Register Association study.

BACKGROUND: Reverse shoulder arthroplasty (RSA) has gained increasing popularity in the treatment of rotator cuff tear arthropathy (CTA). The purpose of this study was to evaluate the survival of RSA and the risk factors for revision following RSA. METHODS: RSA patients with CTA or osteoarthritis were identified from the Nordic Arthroplasty Register Association registry data (2004-2013). Kaplan-Meier survival analysis was used to calculate survival probabilities. Cox multiple regression analysis was used to calculate revision rates adjusted for sex, arthroplasty brand, age (<70 years), and year of surgery. RESULTS: The study included 1904 patients with RSA (1904 RSAs) (69% women; mean age, 74 years; age range, 35-97 years). Revision was performed in 95 patients (5%), with a 10-year cumulative revision rate of 0.91. The most common reason for revision was infection (n = 42), followed by loosening (n = 16) and instability (n = 12). Most revisions occurred less than 6 months after the primary operation. Men had a significantly increased risk of revision compared with women (risk ratio, 3.8; 95% confidence interval, 2.4-6.1). The most common implants were the Delta Xtend (n = 1366) and Delta Mark III (n = 246). The risk of revision of the Delta Mark III was 2.1 (95% confidence interval, 1.1-4.3) compared with the Delta Xtend. Age and year of surgery were not statistically significantly associated with risk of revision. CONCLUSION: The overall midterm risk of revision after RSA for CTA was low (5%). The most common reason for early revision was infection. Male sex was associated with a significantly increased risk of revision.

High risk for revision after shoulder arthroplasty for failed osteosynthesis of proximal humeral fractures.

Background and purpose - It is unclear whether previous osteosynthesis is a risk factor for inferior outcome following shoulder arthroplasty for a proximal humeral fracture. We used data from the Danish Shoulder Arthroplasty Registry (DSR) to examine this question. Patients and methods - All 285 patients treated with a shoulder arthroplasty after failed osteosynthesis of a proximal humeral fracture reported to DSR from 2006 to 2013 were included. Each case was matched with 2 controls (570) treated with a primary shoulder arthroplasty for an acute proximal humeral fracture. Patient reported outcome was assessed using the Western Ontario Osteoarthritis of the Shoulder index (WOOS) and the relative risk of revision was reported. Results - The mean WOOS was 46 (SD 25) for a shoulder arthroplasty after failed osteosynthesis and 52 (27) after a primary shoulder arthroplasty. The relative risk of revision for a shoulder arthroplasty after failed osteosynthesis was 2 with a primary arthroplasty for fracture as reference. In a separate analysis of patients treated by locking plate the mean WOOS was 46 (24), with a relative risk of revision at 1.5 with a primary arthroplasty as reference. Interpretation - Compared with primary arthroplasty for proximal humeral fracture, we found an inferior patient-reported outcome and a substantial risk of revision for patients treated with a shoulder arthroplasty after failed osteosynthesis for a proximal humeral fracture. The risk and burdens of additional surgery should be accounted for when deciding on the primary surgical procedure.

Three Months of Progressive High-Load Versus Traditional Low-Load Strength Training Among Patients With Rotator Cuff Tendinopathy: Primary Results From the Double-Blind Randomized Controlled RoCTEx Trial.

BACKGROUND: Progressive high-load exercise (PHLE) has led to positive clinical results in patients with patellar and Achilles tendinopathy. However, its effects on rotator cuff tendinopathy still need to be investigated. PURPOSE: To assess the clinical effects of PHLE versus low-load exercise (LLE) among patients with rotator cuff tendinopathy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients with rotator cuff tendinopathy were recruited and randomized to 12 weeks of PHLE or LLE, stratified for concomitant administration of corticosteroid injection. The primary outcome measure was change from baseline to 12 weeks in the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, assessed in the intention-to-treat population. RESULTS: A total of 100 patients were randomized to PHLE (n = 49) or LLE (n = 51). Mean changes in the DASH questionnaire were 7.11 points (95% CI, 3.07-11.16) and 8.39 points (95% CI, 4.35-12.44) in the PHLE and LLE groups, respectively; this corresponded to a statistically nonsignificant adjusted mean group difference of -1.37 points (95% CI, -6.72 to 3.99; P = .61). Similar nonsignificant results were seen for pain, range of motion, and strength. However, a significant interaction effect was found between the 2 groups and concomitant corticosteroid use (P = .028), with the largest positive change in DASH in favor of PHLE for the group receiving concomitant corticosteroid. CONCLUSION: The study results showed no superior benefit from PHLE over traditional LLE among patients with rotator cuff tendinopathy. Further investigation of the possible interaction between exercise type and corticosteroid injection is needed to establish optimal and potentially synergistic combinations of these 2 factors. REGISTRATION: NCT01984203 (ClinicalTrials.gov identifier): Rotator Cuff Tendinopathy Exercise Trial (RoCTEx).

A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study).

BACKGROUND: Anterior shoulder dislocation is a common injury and may have considerable impact on shoulder-related quality of life (QoL). If not warranted for initial stabilising surgery, patients are mostly left with little to no post-traumatic rehabilitation. This may be due to lack of evidence-based exercise programmes. In similar, high-impact injuries (e.g. anterior cruciate ligament tears in the knee) neuromuscular exercise has shown large success in improving physical function and QoL. Thus, the objective of this trial is to compare a nonoperative neuromuscular exercise shoulder programme with standard care in patients with traumatic anterior shoulder dislocations (TASD). METHODS/DESIGN: Randomised, assessor-blinded, controlled, multicentre trial. Eighty patients with a TASD will be recruited from three orthopaedic departments in Denmark. Patients with primary or recurrent anterior shoulder dislocations due to at least one traumatic event will be randomised to 12 weeks of either a standardised, individualised or physiotherapist-supervised neuromuscular shoulder exercise programme or standard care (self-managed shoulder exercise programme). Patients will be stratified according to injury status (primary or recurrent). Primary outcome will be change from baseline to 12 weeks in the patient-reported QoL outcome questionnaire, the Western Ontario Shoulder Instability Index (WOSI). DISCUSSION: This trial will be the first study to compare the efficacy and safety of two different nonoperative exercise treatment strategies for patients with TASD. Moreover, this is also the first study to investigate nonoperative treatment effects in patients with recurrent shoulder dislocations. Lastly, this study will add knowledge to the shared decision-making process of treatment strategies for clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02371928 . Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.

Enhanced function and quality of life following 5 months of exercise therapy for patients with irreparable rotator cuff tears - an intervention study.

BACKGROUND: Rotator cuff rupture is associated with dysfunction, pain and muscular weakness related to the upper extremity. Some evidence exists to support the beneficial effect of exercises but there is lack of evidence of which exercises imply the best effect and how physiotherapy should be administered. Therefore, the purpose of this study was to examine the effect of a neuromuscular exercise program for patients with irreparable rotator cuff rupture. METHODS: Based on sample-size calculations thirty patients with chronic irreparable rotator cuff tears (of at least m. supraspinatus and m. infraspinatus) was consecutively included. Twenty-four patients completed the five months training to restore function with focus on centering the humeral head in the glenoid cavity trough strengthening m. deltoideus anterior and m. teres minor. The primary outcome measure was Oxford Shoulder Score which was completed at baseline, 3 and 5 months follow-up. One-way, repeated-measure ANOVA was used if data was normally distributed. Secondary outcome measures included EQ-5D, range of motion, strength and muscle activity. Paired t-test and Wilcoxon Signed Ranks Test was used to the appropriate outcomes. RESULTS: Improvements was seen for both primary and secondary outcomes from baseline to follow-up. Oxford Shoulder Score improved from 25.6 (SD 8.1) at baseline to 33.8 (SD 8.7) at 3 months (p = 0.004) and 37.2 (SD 8.2) at five months (p < 0.001). Range of motion in abduction significantly increased by 34.4° (95 % CI: 11.6-57.2). Strength measured in flexion 45, flexion 90 and abduction also significantly increased at 5 months by 10.2 (95 % CI: 0.8-19.6), 7.0 (95 % CI: 0.0-14.0) and 12.3 (95 % CI: 3.4-21.3) respectively. The remaining outcomes for range of motion and strengths only showed small and non-significant changes. Furthermore patients reported higher levels of quality of life and reduced level of pain after five months. CONCLUSION: Following a five months exercise protocol patients with irreparable rotator cuff tears showed increased function in their symptomatic shoulder, reduced pain and increased quality of life. This study therefore supports the use of exercise therapy in patients with irreparable rotator cuff rupture. TRIAL REGISTRATION: This study is approved by The National Committee on Health Research Ethics (N-20120040) and registered retrospectively at ClinicalTrials.gov in April 2016 ( NCT02740946 ).

Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial.

BACKGROUND: Shoulder pain is the third most common musculoskeletal disorder, often affecting people's daily living and work capacity. The most common shoulder disorder is the subacromial impingement syndrome (SIS) which, among other pathophysiological changes, is often characterised by rotator cuff tendinopathy. Exercise is often considered the primary treatment option for rotator cuff tendinopathy, but there is no consensus on which exercise strategy is the most effective. As eccentric and high-load strength training have been shown to have a positive effect on patella and Achilles tendinopathy, the aim of this trial is to compare the efficacy of progressive high-load exercises with traditional low-load exercises in patients with rotator cuff tendinopathy. METHODS/DESIGN: The current study is a randomised, participant- and assessor-blinded, controlled multicentre trial. A total of 260 patients with rotator cuff tendinopathy will be recruited from three outpatient shoulder departments in Denmark, and randomised to either 12 weeks of progressive high-load strength training or to general low-load exercises. Patients will receive six individually guided exercise sessions with a physiotherapist and perform home-based exercises three times a week. The primary outcome measure will be change from baseline to 12 weeks in the patient-reported outcome Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. DISCUSSION: Previous studies of exercise treatment for SIS have not differentiated between subgroups of SIS and have often had methodological flaws, making it difficult to specifically design target treatment for patients diagnosed with SIS. Therefore, it was considered important to focus on a subgroup such as tendinopathy, with a specific tailored intervention strategy based on evidence from other regions of the body, and to clearly describe the intervention in a methodologically strong study. TRIAL REGISTRATION: The trial was registered with Clinicaltrials.gov ( NCT01984203 ) on 31 October 2013.

Arthroscopic subacromial decompression and predictors of long-term sick leave benefit and permanent benefits.

BACKGROUND: Shoulder impingement syndrome is a common musculoskeletal complaint leading to reduced work ability. The aim of the present study was to identify predictors of long-term sick leave benefit and permanent benefits/permanently reduced work ability after arthroscopic subacromial decompression (ASD). MATERIALS AND METHODS: The study included 615 individuals undergoing ASD (2003 to 2009). Data were linked to the 3 state registries concerning employment/benefits, medication, and industrial injuries. All individuals were monitored for 1 year, and 155 obtained complete 5-year follow-up. Risks were estimated in multivariate logistic regression models. RESULTS: At 1 year after ASD, 16.6% were receiving sick leave benefit. The reduced multiple logistic regression model (odds ratio [95% confidence interval]) included painkillers (2.18 [1.37-3.46]), strong painkillers/opioids (3.78 [2.32-6.16]), and age (0.97 [0.94-0.995]). At 5 years after ASD, 35 (22.6%) were receiving permanent benefit. Predictors (odds ratio [95% confidence interval] were transfer income 2 years before ASD (3.44 [1.20-9.86]), use of opioids at any time during a 1-year period after ASD (24.80 [7.05-87.18]), or other work claims not due to shoulder disease (5.99 [1.34-26.72]). CONCLUSION: A high percentage were receiving sick leave benefit 1 year after ASD, and nearly a quarter were receiving a permanent benefit 5 years after ASD. Medication before ASD was not a predictor of outcome. The strongest predictor of long-term sick leave benefit and permanent benefit was opioid use during the first year after ASD. This may indicate that pain after surgery may be an issue that needs further attention.

Surgeons agree more on treatment recommendations than on classification of proximal humeral fractures.

BACKGROUND: Orthopaedic surgeons disagree considerably when classifying fractures of the proximal humerus. However, the clinical implications of low observer agreement remain unclear. The purpose of the study was to compare the agreement on Neer classification with the agreement on treatment recommendations. METHODS: We conducted a multi-centre observer-study. Five experienced shoulder surgeons independently assessed a consecutive series of 193 radiographs at two occasions three months apart. All pairs of radiographs were classified according to Neer. Subsequently, the observers were asked to recommend one of three treatment modalities for each case: non-operative treatment, locking plate osteosynthesis, or hemiarthroplasty. RESULTS: At both classification rounds mean kappa-values for inter-observer agreement on treatment recommendations (0.48 and 0.52) were significantly higher than the agreement on Neer classification (0.33 and 0.36) (p < 0.001 at both rounds). The highest mean kappa-values were found for inter-observer agreement on non-surgical treatment (0.59 and 0.55). In 36% (345 out of 965) of observations an observer changed Neer category between first and second classification round. However, in only 34% of these cases (116 out of 345) the observers changed their treatment recommendations. CONCLUSIONS: We found a significantly higher agreement on treatment recommendations compared to agreement on fracture classification. The low observer agreement on the Neer classification reported in several observer studies may have less clinical importance than previously assumed. However, inter-observer agreement did not exceed moderate levels.

Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial.

BACKGROUND: Fractures of the proximal humerus are common injuries and account for 4-5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2-10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions. We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management. METHODS/DESIGN: We will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36).

Kinematics of the ligamentous unstable elbow joint after application of a hinged external fixation device: a cadaveric study.

We studied the kinematics of 8 ligamentous unstable elbow joint preparations after application of the Orthofix elbow external fixation device. Valgus, varus, external rotatory, and internal rotatory load tests were performed in lateral collateral ligament (LCL)-deficient and LCL/medial collateral ligament (MCL)-deficient joints. After placement of the fixator, the mean extension decreased significantly to 19.5 degrees +/- 7.2 degrees in the LCL-deficient joint and to 19.1 degrees +/- 6.6 degrees in the LCL/MCL-deficient joint compared with the mean extension of the intact joint, which was 10.5 degrees +/- 4.2 degrees. After application of the fixator, valgus displacement was significantly decreased by 4.0 degrees +/- 3.4 degrees in the LCL-deficient joint and by 3.6 degrees +/- 3.3 degrees in the LCL/MCL-deficient joint compared with the intact joint. External rotatory displacement was significantly decreased in the LCL-deficient joint by 4.9 degrees +/- 3.7 degrees and in the LCL/MCL-deficient joint by 5.0 degrees +/- 4.7 degrees. Internal rotatory displacement was significantly decreased by 3.3 degrees +/- 2.7 degrees in the LCL-deficient joint, but it was not significantly changed in the LCL/MCL-deficient joint. The Orthofix elbow external fixator guided elbow motion to a more varus position compared with the intact elbow and decreased the range of motion of the joint, constraining mainly extension. We conclude that the fixator stabilized the ligamentous unstable elbow joint efficiently but at the expense of changes in the normal motion pattern.

Wrist stability after experimental traumatic triangular fibrocartilage complex lesions.

PURPOSE: The aim of this study was to evaluate changes in stability of the wrist after experimental traumatic triangular fibrocartilage complex lesions. METHODS: Sixteen cadaver wrist specimens were included: 8 were fixed in neutral rotation of the forearm, 4 in maximal supination, and 4 in maximal pronation. The specimens were tested in a multiangle and torque measuring instrument. First the intact specimen was tested, second a dorsal arthrotomy was performed, and the third test was with 1 of 4 different experimental lesions according to Palmer's classification of traumatic triangular fibrocartilage complex lesions (1A-1D). Forced radioulnar deviation and internal/external rotation were recorded with a load of 0.75 Nm in the interval -60 degrees to +60 degrees of flexion. RESULTS: We found the 1C lesion to be highly significantly related to wrist stability. Forced radioulnar deviation and forced internal/external rotation were altered significantly in 35 degrees of wrist extension. The other lesions did not alter the stability of the wrist significantly and the rotation of the forearm had no influence on the outcome. CONCLUSIONS: The 1A lesion does not alter significantly wrist stability and hence the common treatment by a two-third excision of the central part of the disk will not affect wrist stability. A 1C lesion alters significantly the stability of the wrist. At 35 degrees of wrist extension forced radioulnar deviation and forced internal/external rotation were altered significantly; this might be used in a clinical test for a 1C lesion. The rotation of the forearm has no influence on the outcome.