Achilles tendon gait dynamics after rupture: A three-armed randomized controlled trial comparing an individualized treatment algorithm vs. operative or non-operative treatment.

BACKGROUND: Individual treatment selection has been proposed as the key to optimized treatment. The purpose was to investigate if treatment selection using the individualized treatment algorithm Copenhagen Achilles Rupture Treatment Algorithm (CARTA) differs between patients treated as usual regarding gait dynamics and tendon elongation. METHODS: The patients were randomized to one of three parallel groups: 1) intervention group: participants treated according to CARTA, 2) control group: participants treated non-operatively, 3) control group: participants treated operatively. The primary outcome was ankle peak power during push off during walking at 12 months. RESULTS: 156 patients were assessed for eligibility. 21 were allocated to the intervention group, and 20 and 19 to the control groups. The results indicated no statistically significant differences between the intervention group and the control groups. CONCLUSIONS: Individualized treatment selection based on CARTA did not demonstrate less affected gait dynamics or less tendon elongation than patients treated as usual.

Treatment outcome at 1 year did not differ between use of cast or walker in the first 3 weeks after an acute Achilles tendon rupture. A registry study of 1304 patients from the Danish Achilles tendon database.

BACKGROUND: The best choice of orthosis in the treatment of acute Achilles tendon rupture is still under debate. OBJECTIVE: To investigate if choice of orthosis in the first 3 weeks of treatment affected patient reported outcome (Achilles tendon Total Rupture Score (ATRS)), tendon elongation (Achilles Tendon Resting Angle (ATRA) and Heel Rise Height (HRH)) and re-rupture. METHODS: Registry study in the Danish Achilles tendon Database. Patients treated with cast and patients treated with walker in the first 3 weeks of treatment were compared using a linear mixed-effects model adjusted for potential confounders. RESULTS: 1304 patients were included in the study. No clinically relevant difference was found: Adjusted mean difference (using walker the whole period as reference)(95% CI) ATRS after 1 year = 0.1(-3.0; 4.1), ATRS after 6 months = 2.0(-4.5; 5.8), ATRS after 2 years = 3.0(-0.7; 7.0), HRH difference = 0.6(-6.6; 8.2), ATRA difference = 0.03°(-1.5; 1.6), re-rupture(odds ratio) = 0.812(0.4; 1.61). CONCLUSION: Patients treated with cast the first 3 weeks after acute Achilles tendon rupture did not have better treatment outcome than patients treated with walker.

Estimation of Patient Acceptable Symptom State (PASS) and Treatment Failure (TF) Threshold Values for the Achilles Tendon Total Rupture Score (ATRS) at 6 Months, 1 Year, and 2 Years After Acute Achilles Tendon Rupture.

Interpretation of the Achilles tendon Total Rupture Score (ATRS) is challenging because limited knowledge exists about at which score the patients consider the outcome of treatment as satisfactory. The aims of the study were (1) to describe the proportion of patients who find their symptom levels to be satisfactory, to reflect treatment failure or neither after acute Achilles tendon rupture (ATR), and (2) to estimate the Patient Acceptable Symptom State (PASS) and the Treatment Failure (TF) threshold values for the ATRS at 6 months, 1 year, and 2 years after ATR. The study was based on data extracted from the nationwide Danish Achilles tendon Database which includes patients treated operatively or nonoperatively after ATR. The PASS and TF threshold values for ATRS were estimated using the adjusted predictive modeling method. One hundred and sixty-six patients were included at 6 months, 248 patients at 1 year, and 287 patients at 2 years after ATR. The proportion of patients who considered their symptom level to be satisfactory was 61% at 6 months, 50% at 1 year, and 66% at 2 years, while 5% at 6 months, 11% at 1 year, and 10% at 2 years considered their symptom level to reflect treatment failure. The PASS threshold value for ATRS (95% confidence interval) was 49 (46-52) at 6 months, 57 (54-60) at 1 year, and 52 (49-55) at 2 years. The TF threshold value for ATRS was 30 (23-36) at 6 months, 33 (26-40) at 1 year, and 35 (29-39) at 2 years. The calculated PASS and TF threshold values can help interpret the outcome of ATR when measured with the ATRS. About 50% to 66% of the patients had a satisfactory symptom level after ATR.

The Copenhagen Achilles Length Measurement Performed at Time of Acute Achilles Tendon Rupture is Correlated to Tendon Elongation After 1 Year.

Elongation of the tendon has been proposed as the most important factor leading to poor outcome after acute Achilles tendon rupture (ATR). The aim of this paper was to investigate if Amlang's ultrasound classification (AmC) or the Copenhagen Achilles Length Measurement (CALM) when assessed in the acute phase after ATR could predict elongation 1 y after rupture. 107 males and 27 females, aged 18 to 70 y and treated nonsurgically were included. AmC and CALM were assessed at time of rupture and correlated to elongation measured with CALM and Achilles Tendon Resting Angle (ATRA) at 1 y. Receiver operating characteristic (ROC) analysis was performed to determine a cut off for acceptable elongation at time of rupture given that elongation at 1 y was not to exceed 10%. AmC showed no statistically significant correlation. CALM at baseline correlated to CALM at 1 y r = 0.214 (p = .02) and ATRA at 1 y r = 0.218 (p = .02). The ROC model had AUC = 0.67 for 7% elongation at baseline yielding a sensitivity of 0.77 and specificity of 0.50 for predicting elongation of 10% or more at 1 y. Elongation of the Achilles tendon at baseline measured with CALM was weakly correlated to elongation at 1 y. A cut off of 7% elongation at baseline caught 77% of patients who, when treated nonsurgically, ended up with an elongation above 10% at 1 y. A prospective trial investigating CALM as part of a selection algorithm for deciding between operative and nonoperative treatment is needed.

Neither heel-rise Height (HRH) nor Achilles tendon resting angle (ATRA) show strong correlations to patient limitations and return to previous activities one year after acute Achilles tendon rupture.

BACKGROUND: Knowledge is limited about how Achilles tendon elongation following acute Achilles tendon rupture (ATR) affects the ability to return to work and return to sport. This study aimed to examine if the indirect length measures, the heel-rise height (HRH) and the Achilles tendon resting angle (ATRA), correlated with patient limitations and return to previous activities one year after ATR. METHODS: The study was performed as a registry study in the Danish Achilles tendon Database (DADB). The analyses investigated if HRH (limb symmetry index (LSI)) and relative ATRA one year after rupture, correlated with return to the same type of work, return to the same type of sport and the Achilles tendon total rupture score (ATRS) at the same time point. RESULTS: 477 patients were included in the study. HRH (LSI) showed fair correlation to ATRS (r = 0.35, p < 0.001), poor correlation to same type of work (r = 0.29, p < 0.001) and did not statistically significantly correlate with return to the same type of sport. Relative ATRA showed poor correlation to ATRS (r = 0.09, p = 0.04) and did not correlate statistically significantly with return to same type of work or sport. CONCLUSIONS: Neither relative ATRA nor HRH (LSI) showed strong correlations to return to work, return sport or ATRS. When comparing the relative ATRA and HRH (LSI), HRH (LSI) seems to be a better outcome in reflecting patient limitations and return to previous activities one year after ATR.

No clinically relevant difference between operative and non-operative treatment in tendon elongation measured with the Achilles tendon resting angle (ATRA) 1 year after acute Achilles tendon rupture.

PURPOSE: Studies have shown that elongation of the injured Achilles tendon after acute Achilles tendon rupture (ATR) is negatively associated with clinical outcomes. The difference between operative and non-operative treatment on the length of the Achilles tendon is only sparsely investigated. The aim of the study was to investigate if the operative and non-operative treatment of ATR had different effects on tendon elongation. METHODS: The study was performed as a registry study in the Danish Achilles tendon database (DADB). The primary outcome of the study was an indirect measure of Achilles tendon length: the Achilles tendon resting angle (ATRA) at 1-year follow-up. The variable of interest was treatment (operative or non-operative). RESULTS: From August 2015 to January 2019, 438 patients (154 operatively treated and 284 non-operatively treated) were registered with full baseline data and had their ATRA correctly registered at 1-year follow-up in DADB. The analysis did not show a clinically relevant nor statistically significant difference in ATRA between operative and non-operatively treated patients at 1-year follow-up (mean difference - 1.2°; 95% CI - 2.5; 0.1; n.s) after adjustment for potential confounders. CONCLUSION: There were neither clinically relevant nor statistically significant differences in terms of the ATRA at 1-year follow-up between the operative and non-operatively treated patients. This finding suggests that operative treatment does not lead to a clinically relevant reduction in tendon elongation compared to non-operative treatment and it should therefore not be used as an argument in the choice of treatment. LEVEL OF EVIDENCE: Level III.

Diabetes and treatment with orally administrated corticosteroids negatively affect treatment outcome at follow-up after acute Achilles tendon rupture.

PURPOSE: Studies investigating the influence of comorbidities on patient-reported outcomes after acute Achilles tendon ruptures (ATR) are lacking. In this study, the aim was to investigate the effect of comorbidity and medical treatment on the patient-reported outcome measure Achilles tendon total rupture score (ATRS). METHODS: The study was performed as a registry study from the Danish Achilles tendon Database (DADB). In the DADB, ATRS was registered at baseline (prior to rupture), at 3-6 month, 1-year and 2-year follow-ups. The outcomes were ATRS at follow-up and the change in ATRS from baseline to follow-up. Variables of interest were diabetes, hypertension, rheumatic disease and treatment with orally administrated corticosteroids. Linear mixed-effects models including all follow-up time points in the same model were used adjusting for sex, age group, treatment (operative or non-operative) and the investigated comorbidities. RESULTS: Data were collected from 2012 to 2019. Two thousand and four patients with ATR were included. Patients with the investigated comorbidities and treatment with orally administrated corticosteroid scored 10.6-19.1 points lower in mean ATRS at baseline (prior to rupture) compared to patients without the respective disease or treatment. At follow-up, patients with diabetes (mean difference, [95% CI]) (- 6.2, [- 11.7; - 0.8]; P = 0.03) and patients in treatment with orally administrated corticosteroids (- 10.9, [- 16.2; - 5.7]; P < 0.01) had a statistically significantly worse ATRS than patients without the respective disease. However, change in ATRS from baseline to follow-up was not affected. Hypertension and rheumatic disease did not affect ATRS at follow-up but had a positive effect on change in ATRS (4.3, [0.5; 8.1]; P = 0.03) and (12.0, [5.0; 19.9]; P < 0.01), respectively. No other statistically significant differences were found. CONCLUSION: This study showed that patients with diabetes, hypertension, rheumatic disease and patients in treatment with orally administrated corticosteroids had a lower ATRS at baseline (prior to the rupture) when compared to patients without the respective disease or treatment. Diabetes and treatment with orally administrated corticosteroids did negatively affect ATRS at follow-up, but none of the investigated comorbidities or treatment with orally administrated corticosteroids did negatively affect change in ATRS from baseline to follow-up. LEVEL OF EVIDENCE: Level III.

The heel-rise work test overestimates the performed work with 21-25% after an Achilles tendon rupture.

PURPOSE: The purpose of this study was to evaluate concurrent validity of the heel-rise work test performed with use of the heel as a surrogate for the center of body mass. METHODS: The study was a validity study performed on a prospective cohort of consecutive patients. Forty-five patients were included in the study. The heel-rise work test estimates the total work performed by repeated heel-rises until fatigue. In this study, the heel-rise work was assessed by the linear encoder and a motion capture system simultaneously for validation. The linear encoder was attached to the patient's heel and reflective marker was attached to the pelvis and heel. Student's paired t-test, linear regression analysis and Bland Altman plots were used to estimate the measurement error of the linear encoder. RESULTS: The heel-rise work test overestimated the total work with 21.0% on the injured leg and 24.7% on the non-injured leg. Student's paired t-test showed no difference in measurement error between the limbs (n.s.). The linear regression analysis showed no difference in limb symmetry index between the two methods of heel-rise work estimation (a (slope) = 1.00, R = 0.94, p < 0.0001). CONCLUSION: The heel-rise work test performed using the heel as a surrogate for center of body mass overestimates the total work with 21.0-24.7% compared to a gold standard but was able to precisely detect the relative difference between the limbs. The heel marker can be considered a valid measurement device for assessing relative differences between the limbs. CLINICAL RELEVANCE: Clinical testing of injuries to the lower body using the heel-rise work test is valid when using the relative difference between the limbs. LEVEL OF EVIDENCE: I.

The Achilles Tendon Length Measure and the Achilles Tendon Resting Angle show acceptable construct validity using the Copenhagen Achilles Length Measure as gold standard.

BACKGROUND: Elongation of the Achilles tendon after rupture is a frequent complication. The Achilles Tendon Length Measure (ATLM) and the Achilles Tendon Resting Angle (ATRA) are indirect length measures using the resting angle of the ankle. Copenhagen Achilles Length Measure (CALM) is a direct ultrasound measure. The purpose of this study was to examine the construct validity of ATLM and ATRA using CALM as gold standard. METHODS: As the three measurements measure slightly different constructs and have different scales a direct comparison was not possible. Instead a mixed linear regression model was performed investigating the three models: CALM-ATRA, CALMATLM and ATRA-ATLM. RESULTS: 130 patients were available for analysis. All three regression models demonstrated a statistically significant (p < 0.01) linear relationship and acceptable certainty of the estimates. CONCLUSION: ATRA and ATLM were found to have acceptable construct validity when using CALM as gold standard for assessing tendon elongation after an Achilles tendon rupture.

Efficacy of early controlled motion of the ankle compared with immobilisation in non-operative treatment of patients with an acute Achilles tendon rupture: an assessor-blinded, randomised controlled trial.

BACKGROUND: Early controlled motion (ECM) of the ankle is widely used in the non-operative treatment of acute Achilles tendon rupture, although its safety and efficacy have not been investigated properly in a randomised set-up. PURPOSE/AIM OF THE STUDY: To investigate if ECM of the ankle was superior to immobilisation in the treatment of acute Achilles tendon rupture. MATERIALS AND METHODS: This was an assessor-blinded, randomised controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18-70 years were eligible for inclusion. The ECM group performed movements of the ankle five times a day from week 3 to week 8 after rupture. The control group was immobilised for 8 weeks. The primary outcome was the Achilles tendon Total Rupture Score (ATRS) evaluated at 1-year postinjury. The secondary outcomes were heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture. Analysis was conducted as intention-to-treat using inverse probability weighting. FINDINGS/RESULTS: 189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016. There were 64 patients in the ECM group and 58 in the immobilisation group. There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively. HRW was 60% (21) and 60% (21) of the uninjured limb, and elongation was 18 mm (13) and 16 mm (11), respectively. Correspondingly, there were six and seven reruptures. CONCLUSIONS: ECM revealed no benefit compared with immobilisation in any of the investigated outcomes. TRIAL REGISTRATION NUMBER: NCT02015364.

Outcome after acute Achilles tendon rupture is not negatively affected by female sex and age over 65 years.

PURPOSE: Studies suggest that women have worse treatment outcome than men after acute Achilles tendon rupture (ATR). The aim of this study was to investigate if sex and age affect treatment outcome after ATR. METHODS: The study was performed as a registry study in the Danish Achilles tendon Database. The primary outcome was change in the Achilles tendon Total Rupture Score (ATRS) from baseline to 4 months, 1 year and 2 years follow-up. Variables of interest were sex and age group (< 40 years, 40-65 years and > 65 years). RESULTS: Data were collected from April 2012 to March 2018. Five-hundred and sixteen patients (416 men, 100 women) were included in the study population. At baseline, women scored 4.3 points lower in ATRS compared to men. No statistically significant difference between the sexes regarding change in ATRS were found. Women scored statistically significantly less in absolute ATRS at 1 year follow-up (mean difference 9.4; 95% CI 3.8, 14.9; P = 0.03). Patients older than 65 years scored statistically significantly more in ATRS change compared to patients between 40-65 years (mean difference 12.8; 95% CI 6.1-19.5; P < 0.001). CONCLUSION: This study did not show a statistically significant or clinically relevant difference between the sexes in ATRS change from baseline to follow-up. The mean difference in ATRS change between patients older than 65 years and patients between 40-65 years was clinically relevant with better outcome for patients older than 65 years. When comparing ATRS between groups with an unequal sex distribution, the findings of a baseline difference and a difference in absolute ATRS at 1 year follow-up between the sexes, advocate for reporting of sex-specific data or for use of change in ATRS from baseline to follow-up instead of absolute ATRS. LEVEL OF EVIDENCE: Level III.

Reliability of the Copenhagen Achilles length measure (CALM) on patients with an Achilles tendon rupture.

PURPOSE: The primary objective was to examine the reliability of the Copenhagen Achilles length measure (CALM) in patients with an Achilles tendon rupture and secondary to examine the reliability of Achilles tendon resting angle (ATRA) and Achilles tendon length measure (ATLM). METHOD: The study was executed as a cross-sectional study on two different groups: one focused on CALM and the other on ATRA/ATLM. CALM was performed on 56 patients at four timepoints during the first year after injury, whereas ATRA/ATLM were carried out on 28 patients. Intra- and inter-rater reliabilities were determined using the intra-class correlation coefficient (ICC), the standard error of the measurement (SEM), and the minimal detectable change (MDC). RESULTS: For CALM, all measurements, both for injured and non-injured sides as well as for elongation, indicated excellent relative reliability (ICC ≥ 0.75). During the four timepoints, the inter-rater absolute reliability had an SEM that ranged between 0.3 and 0.8 cm (1-4 SEM%) for injured and non-injured sides and 0.3-0.6 cm (18-29 SEM%) for elongation. On an individual level, the inter-rater absolute reliability had an MDC ranging between 0.8 and 2.2 cm (4-11 MDC%) for injured and non-injured sides and 0.8-1.7 cm (47-81 MDC%) for elongation. In the case of ATRA, relative reliability was excellent (ICC ≥ 0.75), and for ATLM, it was fair to excellent (ICC 0.58-0.79). ATRA presented a lower measurement error than ATLM. CONCLUSION: Copenhagen Achilles length measure showed excellent relative reliability, but had a significant measurement error at four timepoints the first year following an Achilles tendon rupture. LEVEL OF EVIDENCE: II.

Development and reliability of the Achilles Tendon Length Measure and comparison with the Achilles Tendon Resting Angle on patients with an Achilles tendon rupture.

BACKGROUND: There is a need for a valid, reliable, and easily applicable clinical measure of the length of the Achilles tendon (AT) after rupture. This study examines the reliability of a new ruler based measurement, the Achilles Tendon Length Measure (ATLM) in comparison with the goniometer-based Achilles Tendon Resting Angle (ATRA). METHODS: Measurements were performed by two independent physiotherapists eight weeks after AT rupture on 28 patients treated non-operatively. RESULTS: The mean (SD) injured ATLM was 56.5 (2.3)cm, ICC2.1 0.91(CI [0.72-0.97]), SEM 0.7cm (SEM% 1.2), MDC 1.9cm (MDC% 3.4). Corresponding data for the injured ATRA was mean 64.4° (3.9°), ICC2.1 0.84 (CI [0.68-0-92]), SEM 1.5° (SEM% 2.4), MDC 4.3° (MDC% 6.6). CONCLUSION: Both ATLM and ATRA showed excellent inter-rater reliability with low measurement error. Both measurements seem easy to use in clinical practice and potentially providing an indirect measure of the length of the AT after rupture.

Achilles tendon Total Rupture Score at 3 months can predict patients' ability to return to sport 1 year after injury.

PURPOSE: To investigate how the Achilles tendon Total Rupture Score (ATRS) at 3 months and 1 year after injury is associated with a patient's ability to return to work and sports as well as to investigate whether sex and age influence ATRS after 3 months and 1 year. METHOD: This is a retrospective study analysing the data from the Danish Achilles tendon Database. A total of 366 patients were included. Logistic regression was conducted to describe the effect of ATRS on return to work and sports. The effect of age and sex on ATRS was analysed by linear regression. RESULTS: Three months after injury patients had a significantly increased chance of return to sport after 1 year with an increased ATRS (OR 1.06, p = 0.001) but a non-significant effect on return to work. After 1 year, patients had a significantly increased probability of having returned to sport (OR 1.11, p < 0.001) and also having returned to work (OR 1.05, p = 0.007) with an increased ATRS. Men had an average 7 (p = 0.006) points higher ATRS at 3 months and an average 22 (p = 0.006) points higher at 1 year. CONCLUSION: ATRS is associated with patients' ability to return to sports and work. ATRS at 3 months can be used as a predictor of the patient's ability to return to sports after 1 year. Hereby, ATRS might help to individualise rehabilitation by identifying patients who do not respond adequately to the chosen treatment. LEVEL OF EVIDENCE: II.

Early Feasibility of an Activity-Based Intervention for Improving Ingestive Functions in Older Adults with Oropharyngeal Dysphagia.

There is growing awareness about the use of combined strength- and skill-based swallowing training for improving swallowing physiology in the event of dysphagia. Such an approach involves focusing on coordination and timing as well as swallowing strengthening in the context of increased exercise complexity in eating and drinking activities. This study aimed to determine the early feasibility of a newly developed 12-week intervention, named the ACT-ING program (ACTivity-based strength and skill training of swallowing to improve INGestion), in older adults with dysphagia and generalized sarcopenia. In a multiple-case-study design, seven participants above 65 years of age (five women and two men) with slight to severe dysphagia and indications of sarcopenia underwent the intervention during hospitalization and in the community after discharge. The ACT-ING program met most of the feasibility marks in terms of demand (73.3% of those invited accepted participation), safety (100%), no reports of adverse events, tolerance (85.7%), usability (100%), and acceptability (100%). Three putative mediators of change (experienced autonomy support, in-therapy engagement, and perceived improvement in swallowing capacity) appeared to have been best accomplished in participants with slight to moderate dysphagia. The ACT-ING program showed preliminary evidence of early feasibility, warranting further early-phase dose articulation and proof-of-concept trials.

Effect of the Copenhagen Achilles Rupture Treatment Algorithm (CARTA) on Calf Muscle Volume and Tendon Elongation After Acute Achilles Tendon Rupture: A Predefined Secondary Analysis of the First 60 Patients in a Randomized Controlled Trial.

Background: Surgical treatment of acute Achilles tendon rupture (ATR) lowers the risk of rerupture and may reduce calf atrophy and elongation of the Achilles tendon. The Copenhagen Achilles Rupture Treatment Algorithm (CARTA) was developed to provide individualized treatment selection based on ultrasonographic evaluation of the rupture. Purpose: In a randomized setup, the present study aimed to investigate whether treatment selection using the CARTA could reduce atrophy and tendon elongation compared with (1) patients treated surgically and (2) patients treated nonsurgically. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 60 patients with an acute ATR were randomly assigned to receive treatment based on the CARTA (intervention), surgical treatment (control), or nonsurgical treatment (control) in a 1 to 1 to 1 ratio. After 1 year, magnetic resonance imaging of both calves was performed, and muscle volume and Achilles tendon length were measured. Results were presented as the ratio between the affected and the unaffected limbs (ie, limb symmetry index; %). Results: A total of 156 patients were assessed for eligibility, 60 patients were randomized, and 54 patients provided data for the study-19 patients received treatment based on the CARTA (intervention group), 17 patients received nonsurgical treatment (control), and 18 patients received surgical treatment (control). No statistically significant differences were found between the intervention group and the 2 control groups regarding muscle volume and tendon length. No statistically significant differences were found between patients treated surgically and patients treated nonsurgically. Comparison between the affected and the unaffected limb showed statistically significant muscle atrophy (24%-30%) and tendon elongation (soleus, 59%-76%; gastrocnemius, 8%-14%) in the affected limb in all 3 groups. Conclusion: Individualized treatment of acute ATR using an ultrasonographic selection algorithm did not reduce calf muscle atrophy or tendon elongation when compared with surgical and nonsurgical treatment. Surgical treatment did not reduce calf muscle atrophy or tendon elongation compared with nonsurgical treatment.

Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial.

BACKGROUND: An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to investigate if this individualized treatment algorithm gives a better functional outcome than treating all patients either operatively or non-operatively per default. METHODS/DESIGN: This study is conducted as a multicenter, three-armed randomized controlled trial. Participants are included from four hospitals in Denmark and randomized 1:1:1 to one of three parallel groups: 1) Intervention group-participants are treated according to an individualized treatment algorithm; 2) Control group A-participants are treated non-operatively; 3) Control group B-participants are treated operatively. The individualized treatment algorithm for the intervention group is based on an ultrasonographic examination; tendon overlap and elongation below 7% is to be treated non-operatively, while no tendon overlap and/or elongation above 7% will be treated operatively. Over a period of 3 years, 300 participants will be included. The primary outcome is the heel-rise work test at 12 months post-injury. Secondary outcomes are tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures, and other complications. The primary analysis will be conducted as an intention-to-treat analysis. DISCUSSION: This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatments instead of offering all the same treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03525964. Registered 16 May 2018.

Performance of the Achilles Tendon Total Rupture Score Over Time in a Large National Database: Development of an Instruction Manual for Accurate Use.

BACKGROUND: The Achilles tendon Total Rupture Score (ATRS) is a commonly used patient-reported outcome measure for patients with an acute Achilles tendon rupture. The score consists of 10 questions, the last 3 of which include activities that some patients cannot or do not do. No instruction manual has been developed for the ATRS. HYPOTHESIS/PURPOSE: The purpose was to evaluate the ATRS at 4, 12, and 24 months after a rupture. The hypothesis was that the results at 4 months would be inconsistent when compared with the results at 1 year and 2 years. We also aimed to develop a manual that explains how to use the ATRS. STUDY DESIGN: Cohort study (Diagnosis); Level of evidence, 3. METHODS: This was a mixed-methods study. The first section was a registry study, where prospectively collected data were analyzed. Data were collected 4, 12, and 24 months after rupture. The original score based on 10 items was compared with a score based on the first 7 items adjusted to the same scale as the original score. Density plots and scatterplots were made and differences between the scores were tested using the Mann-Whitney U test. The second section of the study consisted of discussions among the authors, which resulted in a manual for the ATRS. RESULTS: In total, 2790 complete ATRSs were included. The 7-item score significantly overestimated the value of the 10-item score at all time points (P < .001), but only at 4 months was the difference clinically relevant (9.7 points). CONCLUSION: When the ATRS is used for short-term evaluation, there is a risk of results being inconsistent because of the last 3 questions. A manual explaining how to use the ATRS was therefore developed. We recommend that the full ATRS together with the manual should be used in future research rather than eliminating the 3 last questions.

Completeness and data validity in the Danish Achilles tendon Database.

INTRODUCTION: Acute Achilles tendon rupture is a severe injury causing functional deficits and sick leave. Data from the Danish Achilles tendon Database (DADB) can help us monitor and optimise treatment. The aim of this study was to investigate the completeness and data validity in the DADB. METHODS: The study was performed as a registry study comparing data in the DADB with data from patient records. Data were collected from three of 11 hospitals registered in the DADB. The study was conducted from 1 January to 31 December 2016. A completeness of 80% was considered satisfactory, and a parameter was valid if there was agreement between the DADB and the patient record in 80% of the cases. RESULTS: Overall, completeness was 77% (155/201); for the non-operated patients 81% (150/185) and the operated patients 31% (5/16). The seven investigated parameters all showed a validity of 83-100%. CONCLUSIONS: This study documented a satisfactory completeness of data on the non-operated patients registered in the DADB and an unsatisfactory completeness of data on operated patients. All investigated parameters were valid. These results suggest that data in the DADB on non-operated patients can contribute to research within the field. Due to a limited sample on operated patients, conclusions should be made with caution. The logistics concerning data collection among operated patients warrants optimisation. FUNDING: not relevant. TRIAL REGISTRATION: The study was approved by the Danish Data Protection Agency and the Danish Patient Safety Authority.