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This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TESS V2 Prosthesis | Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TESS V2 | Device | Patients requiring the TESS V2 prosthesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant Shoulder Score | The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function. | Pre-operative, 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Active Anterior Elevation | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees. | Pre-operative, 5 years follow-up |
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Inclusion Criteria:
Except in special cases, the "anatomic" type is indicated for:
Except in special cases, the "reversed" type is indicated for:
Revision in cases of:
Additional inclusion criteria include
Exclusion Criteria:
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Patients in need of Total Shoulder Arthroplasty (primary or revision) who receive the TESS V2 and who meet all of the inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Vivoda | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthokliniek Waasland | Sint-Niklaas | 9100 | Belgium | |||
| Institut Calot |
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| ID | Title | Description |
|---|---|---|
| FG000 | TESS V2 Prosthesis | Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
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| ID | Title | Description |
|---|---|---|
| BG000 | TESS V2 Prosthesis | Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Constant Shoulder Score | The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function. | Number of cases for each time point: 99 (pre-operative) and 50 (5 years follow-up). | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 5 years follow-up |
|
Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TESS V2 Prosthesis | Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision | Surgical and medical procedures | Systematic Assessment | 4 due to dislocation, 1 due to glenoid loosening after a fall, 1 due to patient's dissatisfaction because of limited mobility. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emilie Rohmer, Clinical Ops manager | Zimmer Biomet | +41588548210 | emilie.rohmer@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2012 | Apr 27, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Active Lateral Elevation | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees. | Pre-operative, 5 years follow-up |
| Active External Rotation RE1 | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees. | Pre-operative, 5 years follow-up |
| Active External Rotation RE2 | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees. | Pre-operative, 5 years follow-up |
| Passive Elevation | The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees. | Pre-operative, 5 years follow-up |
| Passive External Rotation | The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees. | Pre-operative, 5 years follow-up |
| Radiographic Evaluation | A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: "unchanged" or "changed" when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of "changed" radiographic evaluations per time point are here reported. | Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up. |
| Survivorship | The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively. | 5 years follow-up |
| Berck |
| 59 |
| France |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | The gender of 2 patients (1.9% of participants) was unspecified in the CRF. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height cm | Height was not available for 4 of the patients. | Mean | Standard Deviation | cm |
|
| Weight kg | Weight was not available for 2 of the patients. | Mean | Standard Deviation | Kg |
|
|
|
| Secondary | Active Anterior Elevation | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees. | Number of cases for each time point: 92 (pre-operative) and 50 (5 years follow-up). | Posted | Mean | Standard Deviation | degrees | Pre-operative, 5 years follow-up |
|
|
|
| Secondary | Active Lateral Elevation | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees. | Number of cases for each time point: 91 (pre-operative) and 50 (5 years follow-up). | Posted | Mean | Standard Deviation | degrees | Pre-operative, 5 years follow-up |
|
|
|
| Secondary | Active External Rotation RE1 | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees. | Number of cases for each time point: 96 (pre-operative) and 50 (5 years follow-up). | Posted | Mean | Standard Deviation | degrees | Pre-operative, 5 years follow-up |
|
|
|
| Secondary | Active External Rotation RE2 | The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees. | Number of cases for each time point: 76 (pre-operative) and 49 (5 years follow-up). | Posted | Mean | Standard Deviation | degrees | Pre-operative, 5 years follow-up |
|
|
|
| Secondary | Passive Elevation | The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees. | Number of cases for each time point: 95 (pre-operative) and 50 (5 years follow-up). | Posted | Mean | Standard Deviation | degrees | Pre-operative, 5 years follow-up |
|
|
|
| Secondary | Passive External Rotation | The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees. | Number of cases for each time point: 95 (pre-operative) and 49 (5 years follow-up). | Posted | Mean | Standard Deviation | degrees | Pre-operative, 5 years follow-up |
|
|
|
| Secondary | Radiographic Evaluation | A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: "unchanged" or "changed" when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of "changed" radiographic evaluations per time point are here reported. | Number of radiographies analysed: 90 immediately post-operative, 83 at 6 weeks follow-up, 85 at 6 months follow-up, 75 at 1 year follow-up, 59 at 2 years follow-up, 36 at 3 years follow-up, 22 at 4 years follow-up, 44 at 5 years follow-up. | Posted | Number | changed radiographies compared to pre-op | No | Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up. | radiographies | radiographies |
|
|
|
| Secondary | Survivorship | The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively. | Number of cases analyzed for each time point: 102 implanted devices (immediate post-operative) and 43 implanted devices (5 years follow-up). | Posted | Number | 95% Confidence Interval | Percentage of implanted devices | 5 years follow-up | implanted devices | implanted devices |
|
|
|
| 5 |
| 106 |
| 44 |
| 106 |
| 16 |
| 106 |
|
| Knee arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Lumbar surgery | Surgical and medical procedures | Systematic Assessment |
|
| Shoulder surgery | Surgical and medical procedures | Systematic Assessment | Other shoulder-related surgical procedures |
|
| Hip arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Hand surgery | Surgical and medical procedures | Systematic Assessment |
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| Elbow arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Death occurred in 1 patient |
|
| Respiratory infection | Infections and infestations | Systematic Assessment |
|
| Stroke | Cardiac disorders | Systematic Assessment | Death occurred in 1 patient |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment | Death occurred in 1 patient |
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| Urinary disorder | Renal and urinary disorders | Systematic Assessment |
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| Kidney disorder | Renal and urinary disorders | Systematic Assessment |
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| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Fracture thoracical vertebrae | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lung edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Death |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Surgery |
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| Knee wound | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgery |
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| Pubis bone fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Wrist fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Conservative treatment |
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| Humerus fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgery |
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| Shoulder fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Conservative treatment |
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| Pseudoarthritis rhizomelic | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hospitalization, infiltrations |
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| Neuropathy and athrosis of inferior limbs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Radius fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgery |
|
| Osteoporosis, fractures | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Acromio-clavicular arthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Rachialgia and scapulalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cubital and Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | Neurolysis |
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| Humerocubital ostephytes | Musculoskeletal and connective tissue disorders | Systematic Assessment | Neurolysis |
|
| Dementia + respiratory infection | General disorders | Systematic Assessment | Death |
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| Weakness | General disorders | Systematic Assessment | Hospitalization |
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| Stress incontinence | General disorders | Systematic Assessment | Surgery |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Vitrectomy | Eye disorders | Systematic Assessment |
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| Head wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cement effraction | Surgical and medical procedures | Systematic Assessment | Surgery |
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| Parkinson | Nervous system disorders | Systematic Assessment |
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| Hyperalgic lumbosciatic | Nervous system disorders | Systematic Assessment | Hospitalization |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Heterotopic ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nerve injury | Nervous system disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Neck pain, paresthesia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shoulder injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Due to fall |
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| Respiratory infection | Infections and infestations | Systematic Assessment |
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| Biceps rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment | On previous tenodesis |
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| Reflex sympathetic syndrom | Nervous system disorders | Systematic Assessment |
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| Postoperative inflammation suspected | Infections and infestations | Systematic Assessment | Resolved with no further consequences |
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| Acromion inflammation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Acromial fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Screw breakage | Surgical and medical procedures | Systematic Assessment | During screwing of inferior screw, the screw touched the Fukuda retractor and broke. Screw was maintained in place, and no problem occurred further. |
|
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| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| 6 weeks follow-up |
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| 6 months follow-up |
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| 1 year follow-up |
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| 2 years follow-up |
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| 3 years follow-up |
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| 4 years follow-up |
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| 5 years follow-up |
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