Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process.

BACKGROUND: Proximal humerus fracture (PHF) complications, whether following surgery or nonoperative management, require standardization of definitions and documentation for consistent reporting. We aimed to define an international consensus core event set (CES) of clinically-relevant unfavorable events of PHF to be documented in clinical routine practice and research. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons selected by survey invitation of AO Trauma members. An organized list of PHF events after nonoperative or operative management was developed and reviewed by panel members using on-line surveys. The proposed core set was revised regarding event groups along with definitions, specifications and timing of occurrence. Consensus was reached with at least a two-third agreement. RESULTS: The PHF consensus panel was composed of 231 clinicians worldwide who responded to at least one of two completed surveys. There was 93% final agreement about three intraoperative local event groups (device, osteochondral, soft tissue). Postoperative or nonoperative event terms and definitions organized into eight groups (device, osteochondral, shoulder instability, fracture-related infection, peripheral neurological, vascular, superficial soft tissue, deep soft tissue) were approved with 96 to 98% agreement. The time period for documentation ranged from 30 days to 24 months after PHF treatment depending on the event group and specification. The resulting consensus was presented on a paper-based PHF CES documentation form. CONCLUSIONS: International consensus was achieved on a core set of local unfavorable events of PHF to foster standardization of complication reporting in clinical research and register documentation. TRIAL REGISTRATION: Not applicable.

Complications Within 6 Months After Arthroscopic Rotator Cuff Repair: Registry-Based Evaluation According to a Core Event Set and Severity Grading.

PURPOSE: To report complications after arthroscopic rotator cuff repairs (ARCRs) in a large patient cohort based on clinical application of a newly defined core event set (CES) and severity grading. METHODS: Consecutive primary ARCRs documented in a local clinical registry between February 2010 and September 2016 were included. Clinicians documented adverse events (AEs) reported until the final, 6-month postoperative follow-up according to the CES. The CES is an organized list of relevant AEs sorted into 3 intraoperative event groups (device, osteochondral, and soft tissue) and 9 postoperative event groups (device, osteochondral, pain, rotator cuff, surgical-site infection, peripheral neurologic, vascular, superficial soft tissue, and deep soft tissue). Severity was determined using an adaptation of the Clavien-Dindo classification. Cumulative complication risks were calculated per event group and stratified by severity and rotator cuff tear extent. RESULTS: A total of 1,661 repairs were documented in 1,594 patients (mean age, 57 years [standard deviation, 9 years]; 38% women); 21% involved partial tears. All events were recorded according to the CES. Intraoperative events occurred in 2.2% of repairs. We identified 329 postoperative events in 307 repairs (305 patients); 93% had 1 AE. The cumulative AE risk at 6 months was 18.5%; AE risks were 21.8% for partial tears, 15.8% for full-thickness single-tendon tears, 18.0% for tears with 2 ruptured tendons, and 25.6% for tears with 3 ruptured tendons. AE risks per event group were as follows: 9.4% for deep soft tissue, with shoulder stiffness (7.6%) being the most common event; 3.4% for persistent or worsening pain; 3.1% for rotator cuff defects; 1.7% for neurologic lesions; 0.8% for surgical-site infection; 0.7% for device; 0.4% for osteochondral; 0.2% for superficial soft tissue, and 0.1% for vascular. Most AEs had severity grades I (160 [49%]) and II (117 [36%]). CONCLUSIONS: Comprehensive local AE documentation according to the CES and severity grading was possible and showed that about one-fifth of ARCRs were affected, mostly by one AE of low severity. Shoulder stiffness was the most frequent event. LEVEL OF EVIDENCE: Level IV, case series.

Core set of unfavorable events of shoulder arthroplasty: an international Delphi consensus process.

BACKGROUND: Shoulder arthroplasty (SA) complications require standardization of definitions and are not limited to events leading to revision operations. We aimed to define an international consensus core set of clinically relevant unfavorable events of SA to be documented in clinical routine practice and studies. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder surgeons selected by nomination through professional societies. On the basis of a systematic review of terms and definitions and previous experience in establishing an arthroscopic rotator cuff repair core set, an organized list of SA events was developed and reviewed by panel members. After each survey, all comments and suggestions were considered to revise the proposed core set including local event groups, along with definitions, specifications, and timing of occurrence. Consensus was reached with at least two-thirds agreement. RESULTS: Two online surveys were required to reach consensus within a panel involving 96 surgeons. Between 88% and 100% agreement was achieved separately for local event groups including 3 intraoperative (device, osteochondral, and soft tissue) and 9 postoperative event groups. Experts agreed on a documentation period that ranged from 3 to 24 months after SA for 4 event groups (peripheral neurologic, vascular, surgical-site infection, and superficial soft tissue) and that was lifelong until implant revision for other groups (device, osteochondral, shoulder instability, pain, late hematogenous infection, and deep soft tissue). CONCLUSION: A structured core set of local unfavorable events of SA was developed by international consensus to support the standardization of SA safety reporting. Clinical application and scientific evaluation are needed.

Towards standardised definitions of shoulder arthroplasty complications: a systematic review of terms and definitions.

INTRODUCTION: A transparent, reliable and accurate reporting of complications is essential for an evidence-based evaluation of shoulder arthroplasty (SA). We systematically reviewed the literature for terms and definitions related to negative events associated with SA. MATERIALS AND METHODS: Various biomedical databases were searched for reviews, clinical studies and case reports of complications associated with SA. Any general definition of a complication, classification system, all reported terms related to complications and negative events with their definitions were extracted. Terms were grouped and organised in a hierarchical structure. Definitions of negative events were tabulated and compared. RESULTS: From 1086 initial references published between 2010 and 2014, 495 full-text papers were reviewed. Five reports provided a general definition of the term "surgical complication" and 29 used a classification system of complications. A total of 1399 extracted terms were grouped based on similarities and involved implant or anatomical parts. One hundred and six reports (21.4%) defined at least one negative event for 28 different terms. There were 64 definitions related to humeral or glenoid loosening, and 25 systems documenting periprosthetic radiolucency. Other definitions considered notching, stress shielding, implant failure and tuberosity malposition. CONCLUSIONS: A clear standardised set of SA complication definitions is lacking. Few authors reported complications based on definitions mainly considering radiological criteria without clinical parameters. This review should initiate and support the development of a standardised SA complication core set.

Complications associated with arthroscopic rotator cuff tear repair: definition of a core event set by Delphi consensus process.

BACKGROUND: The literature does not consistently report on complications associated with arthroscopic rotator cuff repair (ARCR). Valid comparison of the occurrence of complications between ARCR interventions requires standardization. This project was implemented to define a core set of negative (untoward) events associated with ARCR along with their terms and definitions, which should be systematically documented and reported in routine care and clinical research. MATERIALS AND METHODS: A Delphi consensus process was applied. An international panel of experienced shoulder surgeons was nominated through professional societies and personal contacts. On the basis of a systematic review of terms and definitions, an organized list of relevant events associated with ARCR was developed and reviewed by panel members. Between each survey, all comments and suggestions were considered to revise the proposed core set, including local event groups along with definitions, specifications, and timing of occurrence. Consensus was defined as at least two-thirds agreement. RESULTS: Three successive online surveys were implemented involving 84 surgeons. Consensus with over 86% agreement was reached for a core list of local events including 3 intraoperative event groups (device, osteochondral, and soft tissue) and 9 postoperative event groups (device, osteochondral, pain, rotator cuff, surgical-site infection, peripheral neurologic, vascular, superficial soft tissue, and deep soft tissue). Experts agreed on a period for documentation of each event or group of events ranging from 3 to 24 months after ARCR. CONCLUSION: A structured core set of local events associated with ARCR has been developed by international consensus. Further evaluation and validation in the context of clinical studies are required.

Patterns of proximal humeral bone resorption after total shoulder arthroplasty with an uncemented rectangular stem.

BACKGROUND: The aim of this study was to assess the timing and location of cortical bone resorption after total shoulder arthroplasty with an uncemented rectangular stem and investigate its effect on shoulder function up to 5 years after implantation. METHODS: Between June 2003 and September 2006, 183 consecutive total shoulder arthroplasties were performed, 133 of which received a cementless rectangular stem as indicated by primary or post-traumatic osteoarthritis (OA). The 5-year postoperative follow-up rate was 80%. Standardized radiographic controls and clinical assessments were performed at 6 weeks, 6 months, and 1, 2, and 5 years. RESULTS: Twenty-two patients (17%) showed full-thickness cortical bone resorption, 21 of whom were diagnosed with Sperling zone 2 resorption. The maximum craniocaudal distance of full resorption averaged 19.1 mm (range, 5.6-46.7 mm). The median distance progressed significantly from 9.6 mm to 13.8 mm between 6 and 12 months (P = .005). The risk of bone resorption was 3.1 times higher for post-traumatic OA patients than for those with primary OA. The occurrence of bone resorption increased significantly with increasing stem diameters relative to the humeral diameter. There was no significant effect of bone resorption on functional outcome. CONCLUSION: Full-thickness cortical bone resorption in the proximal posterolateral humerus after receipt of a cementless rectangular stem has a prevalence of 17%, mostly occurring within the first year after surgery. Risk factors include age, post-traumatic conditions, and larger stem sizes relative to the humerus. This is a radiographic phenomenon without significant impairment of function or need for revision within 5 years after surgery.

Functional and Radiologic Outcomes of Degenerative Versus Traumatic Full-Thickness Rotator Cuff Tears Involving the Supraspinatus Tendon.

BACKGROUND: Arthroscopic rotator cuff repair (ARCR) is among the most commonly performed orthopaedic procedures. Several factors-including age, sex, and tear severity-have been identified as predictors for outcome after repair. The influence of the tear etiology on functional and structural outcome remains controversial. PURPOSE: To investigate the influence of tear etiology (degenerative vs traumatic) on functional and structural outcomes in patients with supraspinatus tendon tears. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Patients undergoing ARCR from 19 centers were prospectively enrolled between June 2020 and November 2021. Full-thickness, nonmassive tears involving the supraspinatus tendon were included. Tears were classified as degenerative (chronic shoulder pain, no history of trauma) or traumatic (acute, traumatic onset, no previous shoulder pain). Range of motion, strength, the Subjective Shoulder Value, the Oxford Shoulder Score (OSS), and the Constant-Murley Score (CMS) were assessed before (baseline) and 6 and 12 months after ARCR. The Subjective Shoulder Value and the OSS were also determined at the 24-month follow-up. Repair integrity after 12 months was documented, as well as additional surgeries up to the 24-month follow-up. Tear groups were compared using mixed models adjusted for potential confounding effects. RESULTS: From a cohort of 973 consecutive patients, 421 patients (degenerative tear, n = 230; traumatic tear, n = 191) met the inclusion criteria. The traumatic tear group had lower mean baseline OSS and CMS scores but significantly greater score changes 12 months after ARCR (OSS, 18 [SD, 8]; CMS, 34 [SD,18] vs degenerative: OSS, 15 [SD, 8]; CMS, 22 [SD, 15]) (P < .001) and significantly higher 12-month overall scores (OSS, 44 [SD, 5]; CMS, 79 [SD, 9] vs degenerative: OSS, 42 [SD, 7]; CMS, 76 [SD, 12]) (P≤ .006). At the 24-month follow-up, neither the OSS (degenerative, 44 [SD, 6]; traumatic, 45 [SD, 6]; P = .346) nor the rates of repair failure (degenerative, 14 [6.1%]; traumatic 12 [6.3%]; P = .934) and additional surgeries (7 [3%]; 7 [3.7%]; P = .723) differed between groups. CONCLUSION: Patients with degenerative and traumatic full-thickness supraspinatus tendon tears who had ARCR show satisfactory short-term functional results. Although patients with traumatic tears have lower baseline functional scores, they rehabilitate over time and show comparable clinical results 1 year after ARCR. Similarly, degenerative and traumatic rotator cuff tears show comparable structural outcomes, which suggests that degenerated tendons retain healing potential.

International consensus for a core radiological monitoring protocol of proximal humerus fractures.

BACKGROUND: Proximal humerus fractures (PHF) should be subject to standardized monitoring during treatment, whether non-operative or operative, to document and adequately assess bone healing. The purpose of this study was to develop a standardized protocol for an image-based monitoring of PHF for joint-preserving treatment options, including a minimum set of descriptors or definitions of features of radiographic images, to be applied in clinical routine practice and studies. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons self-selected after invitation of all AO Trauma members. Using open questions participants recommended the type and timing of desired diagnostic images, and formulated definitions for the imaging parameters they considered most important. Formulated recommendations for the type and timing of radiological fracture monitoring and clarification of the definitions of the proposed radiological parameter set were subjected to further survey. Consensus for each factor was considered to have been reached when there was at least a two-thirds agreement in the survey participants. RESULTS: Response rates of 231 interested surgeons were 66% and 44% for the first and second survey respectively. Sixty percent of participants to the first survey responded to the second (131/219). 93% of respondents considered radiographic monitoring to be an important part of fracture care. 92% of respondents to the first survey considered that 'malreduction' should be assessed, and 165 of 189 respondents provided a suggestion for a definition for this parameter. 88% of respondents to the second survey agreed on a redefinition of the term 'malreduction' as 'non-anatomical fracture reduction'. There was substantial agreement about the radiographic views and orientation of radiographs to be recorded (80%) and the timing of radiological reviews (67- 78% for time points during follow up). Just over half of respondents recommended cessation of radiological review when fracture healing was considered to have occurred by radiological evaluation. CONCLUSION: Our work confirmed the need for clear definitions of radiological features that should be considered in the follow-up of proximal humeral fractures. It has resulted in the development of an international consensus monitoring protocol for PHF treatment with a structured core set of radiological parameters. Clinical application and validation of the monitoring process are needed.

Anchor Site Fracture Following Arthroscopic Rotator Cuff Repair - A Case Report and Review of the Literature.

INTRODUCTION: Fractures at the anchor site following arthroscopic rotator cuff repair are rare and only a few case reports have been described. We report two additional well-documented cases of this uncommon post-operative complication and provide a review of the current literature. CASE REPORT: A 48-year-old male underwent arthroscopic rotator cuff repair (ARCR) due to a massive rotator cuff tear. Nine weeks postoperatively, the patient suffered a humeral head fracture at the anchor site of the ARCR after trauma. Despite subsequent surgical treatment with open reduction and internal fixation, the patient demonstrates with excellent functional outcome scores at 2-year follow-up. CONCLUSION: Humeral head fractures are a rare complication after ARCR. The use of intraosseous anchors requires careful consideration regarding positioning and quantity used.

Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study.

INTRODUCTION: In the field of arthroscopic rotator cuff repair (ARCR), reporting standards of published studies differ dramatically, notably concerning adverse events (AEs). In addition, prognostic studies are overall methodologically poor, based on small data sets and explore only limited numbers of influencing factors. We aim to develop prognostic models for individual ARCR patients, primarily for the patient-reported assessment of shoulder function (Oxford Shoulder Score (OSS)) and the occurrence of shoulder stiffness 6 months after surgery. We also aim to evaluate the use of a consensus core event set (CES) for AEs and validate a severity classification for these events, considering the patient's perspective. METHODS AND ANALYSIS: A cohort of 970 primary ARCR patients will be prospectively documented from several Swiss and German orthopaedic clinics up to 24 months postoperatively. Patient clinical examinations at 6 and 12 months will include shoulder range of motion and strength (Constant Score). Tendon repair integrity status will be assessed by ultrasound at 12 months. Patient-reported questionnaires at 6, 12 and 24 months will determine functional scores (subjective shoulder value, OSS), anxiety and depression scores, working status, sports activities, and quality of life (European Quality of Life 5 Dimensions 5 Level questionnaire). AEs will be documented according to a CES. Prognostic models will be developed using an internationally supported regression methodology. Multiple prognostic factors, including patient baseline demographics, psychological, socioeconomic and clinical factors, rotator cuff integrity, concomitant local findings, and (post)operative management factors, will be investigated. ETHICS AND DISSEMINATION: This project contributes to the development of personalised risk predictions for supporting the surgical decision process in ARCR. The consensus CES may become an international reference for the reporting of complications in clinical studies and registries. Ethical approval was obtained on 1 April 2020 from the lead ethics committee (EKNZ, Basel, Switzerland; ID: 2019-02076). All participants will provide informed written consent before enrolment in the study. TRIAL REGISTRATION NUMBER: NCT04321005. PROTOCOL VERSION: Version 2 (13 December 2019).

Core Set of Radiographic Parameters for Shoulder Arthroplasty Monitoring: Criteria Defined by an International Delphi Consensus Process.

Some unfavorable local events following shoulder arthroplasty occur without the patient experiencing symptoms and yet may be detected on diagnostic imaging, thereby serving as indicators of complications that may require revision. Our aim was to create a standardized protocol for an image-based monitoring process for assessing patients who are asymptomatic following shoulder arthroplasty. METHODS: A Delphi exercise was implemented with the participation of an international panel of experienced shoulder surgeons. On the basis of expert opinion from a core steering group, an initial list of imaging parameters for shoulder arthroplasty monitoring of asymptomatic patients was developed and reviewed by panel members. The most appropriate imaging modality was identified. Between each survey, all feedback was considered in order to revise the proposed core set with its definitions and specifications. Consensus was reached upon a two-thirds agreement. RESULTS: Three online surveys were administered, with 98 surgeons responding to the first and/or the second survey. The response rate for the final survey was 74%. Final parameter definitions were organized in 7 categories (implant migration, radiolucency around implant and implant loosening, signs of shoulder displacement, bone resorption and formation, wear of implant articular surfaces, fractures around the implant, and implant breakage and disassembly) and approved with 85% to 100% agreement. Seventy-eight percent of the panel members agreed on a minimum radiographic imaging schedule: standard anteroposterior and axial (alternatively, Y) views made within 6 weeks after implantation and between 3 and 6 months as well as at 12 months post-surgery. CONCLUSIONS: Our work presents a monitoring tool developed with international consensus for the assessment of asymptomatic patients after shoulder arthroplasty and including a structured core set of radiographic parameters. Clinical application and scientific evaluation of the monitoring process are needed. CLINICAL RELEVANCE: This represents a major step toward the standardization of shoulder arthroplasty radiographic monitoring for routine quality controls and research investigations.

Combined displaced fracture of the lesser humeral tuberosity and the scapular spine: A case report.

UNLABELLED: Introduction Combined displaced fractures of the lesser humeral tuberosity and the scapular spine are highly uncommon and have not been previously reported in literature. CASE PRESENTATION: The authors report a novel case of a 24 year-old male who sustained displaced fractures of the lesser humeral tuberosity and the scapular spine. Open reduction and internal fixation (ORIF) was performed with a LCP T-plate for the lesser tuberosity and with a LCP Distal Humerus Plate for the scapular spine. At one year, both fractures healed in anatomical alignment and the patient achieved good range of motion and a Constant score of 94 points. DISCUSSION: While isolated fractures of the scapular spine and the lesser tuberosity can be treated conservatively, combination fractures as in the present case are highly unstable. While sufficient evidence is lacking to favor surgical treatment over conservative management, ORIF provided sufficient stability for early mobilization and led to good clinical results. CONCLUSION: Based on the favorable outcome of our case, we provide useful recommendations for surgeons faced with similar injuries.

Complications Following Arthroscopic Rotator Cuff Tear Repair: A Systematic Review of Terms and Definitions With Focus on Shoulder Stiffness.

BACKGROUND: Valid comparison of outcomes after surgical procedures requires consensus on which instruments and parameters should be used, including the recording and evaluation of surgical complications. An international standard outlining the terminology and definitions of surgical complications in orthopaedics is lacking. PURPOSE: This study systematically reviewed the literature for terms and definitions related to the occurrence of negative events or complications after arthroscopic rotator cuff repair (ARCR) with specific focus on shoulder stiffness. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: PubMed, EMBASE, Cochrane Library, and Scopus databases were searched for reviews, clinical studies, and case reports of complications associated with ARCR. Reference lists of selected articles were also screened. The terminology of complications and their definitions were extracted from all relevant original articles by a single reviewer and verified by a second reviewer. Definitions of shoulder stiffness or equivalent terms were tabulated. RESULTS: Of 654 references published after 2007 and obtained from the search, 233 full-text papers (44 reviews, 155 studies, 31 case reports, and 3 surgical technique presentations) were reviewed. Twenty-two additional references cited for a definition were checked. One report defined the term surgical complication. There were 242 different terms used to describe local events and 64 to describe nonlocal events. Furthermore, 16 definitions of terms such as frozen shoulder, shoulder stiffness, or stiff painful shoulder were identified. Diagnosis criteria for shoulder stiffness differed widely; 12 various definitions for restriction in range of motion were noted. One definition included a gradation of stiffness severity, whereas another considered the patient's subjective assessment of motion. CONCLUSION: The literature does not consistently report on complications after ARCR, making valid comparison of the incidence of these events among published reports impossible. Specifically, the variation in criteria used to diagnose shoulder stiffness is problematic for valid and accurate reporting of this event. A standard for reporting this event and other complications after ARCR is needed. CLINICAL RELEVANCE: This review serves as the basis for the development of a uniform documentation process for shoulder stiffness and the standardization of complication definitions in ARCR following international consensus.

Scapula fractures: interobserver reliability of classification and treatment.

OBJECTIVES: There is substantial variation in the classification and management of scapula fractures. The first purpose of this study was to analyze the interobserver reliability of the OTA/AO classification and the New International Classification for Scapula Fractures. The second purpose was to assess the proportion of agreement among orthopaedic surgeons on operative or nonoperative treatment. DESIGN: Web-based reliability study. SETTING: Independent orthopaedic surgeons from several countries were invited to classify scapular fractures in an online survey. PARTICIPANTS: One hundred three orthopaedic surgeons evaluated 35 movies of three-dimensional computerized tomography reconstruction of selected scapular fractures, representing a full spectrum of fracture patterns. MAIN OUTCOME MEASUREMENTS: Fleiss kappa (κ) was used to assess the reliability of agreement between the surgeons. RESULTS: The overall agreement on the OTA/AO classification was moderate for the types (A, B, and C, κ = 0.54) with a 71% proportion of rater agreement (PA) and for the 9 groups (A1 to C3, κ = 0.47) with a 57% PA. For the New International Classification, the agreement about the intraarticular extension of the fracture (Fossa (F), κ = 0.79) was substantial and the agreement about a fractured body (Body (B), κ = 0.57) or process was moderate (Process (P), κ = 0.53); however, PAs were more than 81%. The agreement on the treatment recommendation was moderate (κ = 0.57) with a 73% PA. CONCLUSIONS: The New International Classification was more reliable. Body and process fractures generated more disagreement than intraarticular fractures and need further clear definitions.