Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reverse Shoulder Arthroplasty with subscapularis repair | Experimental | The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique. |
|
| Reverse Shoulder Arthroplasty without subscapularis repair | No Intervention | The subscapularis will not be repaired. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repair of the subscapularis | Device | The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant-Murley Shoulder Outcome Score | 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. | Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure. |
| Constant-Murley Shoulder Outcome Score | 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. | Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure. |
| Constant-Murley Shoulder Outcome Score | 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. | Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure. |
| Constant-Murley Shoulder Outcome Score | 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. | Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure. |
| Constant-Murley Shoulder Outcome Score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound | 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". | Collected once at either the 6 month, 1 year or 2 year timepoint. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly A Ganz | Contact | 1 (800) 933-7001 | 71119 | kelly.ganz@arthrex.com |
| Samantha Martino | Contact | 1 (800) 933-7001 | 71970 | samantha.martino@arthrex.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona/Banner Health | Recruiting | Phoenix | Arizona | 85006 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
The patients will be randomly allocated in a 1:1 ratio, with block sizes of four and six using a randomization sequence.
Not provided
Not provided
Not provided
Not provided
| Collected at the 2 year post-op timepoint, and is the primary outcome measure |
| American Shoulder and Elbow Surgeons (ASES) subjective survey | 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. | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. |
| Simple Shoulder Test (SST) questionnaire | Provides a standardized way of recording the function of a shoulder before and after treatment. | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. |
| Visual Analog Scale (VAS) | The standard measure for pain on a 0-10 scale, 10 being the worst. | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. |
| Western Ontario Osteoarthritis of the Shoulder Index (WOOS) | 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. | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. |
| Veterans Rand 12 Item Health Survey (VR-12) | 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. | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. |
| Single Assessment Numeric Evaluation score (SANE) | Asks patients to rate shoulder pain as a percentage of normal. | Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. |
| Standard Pre-Operative Form | A patient administered form that asks patients to evaluate their expectations of their scheduled Arthroplasty procedure. | Collected at the pre-op visit. |
| Return to Work Form | A patient administered form that asks patients to determine the effect that their shoulder has had on their employment. | Collected at pre-op, 26 weeks and 1 year. |
| Standard Late Postoperative Form | A patient administered form that asks patient to evaluate if their expectations were met regarding their Arthroplasty procedure. | Collected at the 1 year and 2 year timepoints. |
| Western Orthopaedics, P.C. | Not yet recruiting | Denver | Colorado | 80218 | United States |
|
| Southern Oregon Orthopedics | Recruiting | Medford | Oregon | 97504 | United States |
|
| The Hawkins Foundation | Recruiting | Greenville | South Carolina | 29615 | United States |
|
| The Campbell Clinic | Recruiting | Collierville | Tennessee | 38017 | United States |
|
| Jordan Young Institute | Recruiting | Norfolk | Virginia | 23462 | United States |
|
| D000070657 |
| Crystal Arthropathies |