Rotator Cuff Tear Arthropathy
Conditions
Brief summary
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
Detailed description
The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative. Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.
Interventions
DEVICERepair of the subscapularis
The subscapularis will be repaired using the suture through bone and prosthesis holes surgical technique.
Sponsors
Arthrex, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The patients will be randomly allocated in a 1:1 ratio, with block sizes of four and six using a randomization sequence.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system. 2. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy. 3. Patient meets FDA cleared indications for reverse shoulder arthroplasty 4. Patient is between 18-100 years old 5. Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study 6. Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning
Exclusion criteria
1. Patient has a history of ipsilateral shoulder arthroplasty 2. A history of shoulder septic arthritis 3. A full thickness subscapularis tear 4. An acute or malunited proximal humeral fracture 5. Chronic locked dislocation 6. Rheumatoid arthritis 7. Tumors 8. Axillary nerve damage 9. Non-functioning deltoid muscle 10. Glenoid vault deficiency precluding baseplate fixation 11. Infection and neuropathic joints 12. Known or suspected non-compliance, drug or alcohol abuse 13. Patients incapable of judgement or under tutelage 14. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. 15. The subject is related to investigator as family members, employees, or other dependent persons 16. Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley Shoulder Outcome Score | Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure. | A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) subjective survey | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. | A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient. |
| Simple Shoulder Test (SST) questionnaire | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. | Provides a standardized way of recording the function of a shoulder before and after treatment. |
| Visual Analog Scale (VAS) | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. | The standard measure for pain on a 0-10 scale, 10 being the worst. |
| Western Ontario Osteoarthritis of the Shoulder Index (WOOS) | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. | A patient administrated questionnaire for measurement of the quality of life. It provides scores on four domains: 1.) physical symptoms, 2.) sport, recreation, and work, 3.) lifestyle and 4.) emotions. |
| Ultrasound | Collected once at either the 6 month, 1 year or 2 year timepoint. | Evaluation of the subscapularis complex in patients that have been randomized to repair of the subscapularis to examine the subscapularis complex. Ultrasound scans will be read and the integrity of the subscapularis complex will be determined by the clinician to be intact, attenuated, partial tear or complete tear. |
| Single Assessment Numeric Evaluation score (SANE) | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. | Asks patients to rate shoulder pain as a percentage of normal. |
| Standard Pre-Operative Form | Collected at the pre-op visit. | A patient administered form that asks patients to evaluate their expectations of their scheduled Arthroplasty procedure. |
| Return to Work Form | Collected at pre-op, 26 weeks and 1 year. | A patient administered form that asks patients to determine the effect that their shoulder has had on their employment. |
| Standard Late Postoperative Form | Collected at the 1 year and 2 year timepoints. | A patient administered form that asks patient to evaluate if their expectations were met regarding their Arthroplasty procedure. |
| Veterans Rand 12 Item Health Survey (VR-12) | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. | A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status. |
Countries
United States
Contacts
Primary ContactKelly A Ganz
Backup ContactSamantha Martino
Outcome results
None listed