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This study was withdrawn because 1) we did not secure needed funding, and 2) the research question became less important while we were waiting for funding opportunities as a few similar studies got published. We have no plan to pursue this study.
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| Name | Class |
|---|---|
| Harry S. Truman Memorial Veterans' Hospital | FED |
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Notwithstanding the rapid increase in utilization of reverse total shoulder arthroplasty (RTSA), little consensus or high-quality evidence exists regarding optimal rehab methods following the procedure. Our research question is how different rehab methods influence the clinical outcomes following RTSA. This proposal presents a prospective randomized clinical trial where 100 eligible RTSA patients will be randomly assigned to two rehab groups (Short immobilization with patient-directed therapy vs Long immobilization with supervised therapy) at a single institution. Patient-reported outcomes, objective clinical data, and complications will be compared between the groups over a period of 2 years.
The investigators will perform a prospective randomized non-blinded clinical study where the investigators will recruit a total of 100 patients undergoing RTSA at our institution according to the inclusion and exclusion criteria. Participants will be randomly assigned to one of two rehab groups (50 in each group) - short immobilization combined with patient-directed home therapy (Patient-led rehab) vs long immobilization combined with supervised physical therapy (Supervised rehab) - using a randomization protocol developed by our biostatistics department. The group assignment will be kept sealed in an envelope until the day of surgery to blind both the patients and surgeons.
Surgical procedure and postoperative rehabilitation Enrolled patients will undergo RTSA with one of the two shoulder and elbow surgeons under general anesthesia combined with interscalene block. A standard deltopectoral approach will be used, and the subscapularis tendon will be repaired using transosseous sutures if it is reparable. Tornier reverse shoulder arthroplasty system (Ascent Flex humeral stem with 132.5°inclincation angle, standard Perform Reversed glenoid components, and standard polyethylene liner) will be used in all patients. The size of the humeral stem, baseplate, glenosphere, and polyethylene liner will be chosen on the basis of the patient's anatomy. A sling with an abduction pillow will be used for postoperative immobilization in 30° abduction and 45° internal rotation in all patients. The patient-led rehab group will be educated on their postoperative rehab in detail prior to surgery. The detailed rehab methods for each group are as follows.
Postoperative outcome evaluation Strict adherence to the rehab protocol will be encouraged and monitored during the rehab period. The research coordinator will contact patients twice a week for the first 2 weeks and then once a week for the following 2 weeks. Patients will be given a pain diary where they will record their pain levels daily along with their daily narcotic use for the first 2 weeks. Patients will return for follow-up, undergo x-rays, and will be evaluated at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The following data will be obtained during the study period.
Statistical analysis Sample size calculation: Sample size was calculated to examine the superiority of patient-led rehab over supervised rehab. The null hypothesis is that there is no difference in the primary outcome measure (ASES score at 6 months) between the two rehab methods. Considering similar protocols in the literature12-14 and a mean difference in ASES scores of 11 points with corresponding standard deviation of 18 points, a minimum of 100 patients (50 for each group) are needed to achieve at least 80% power using a two-sided type I error of 0.05. These numbers account for a 10% patient attrition.
Statistical methods: Intention-to-treat analysis will be used for this randomized clinical trial study. Patients who are lost to follow up (dropout), do not comply with their assigned rehab method based on criteria (noncompliance), or change to the other rehab method (cross-over) will be analyzed according to their original group assignment. If there is greater than 10% of data is missing, the group data will be treated according to a missing data protocol - multiple imputation method under a missing at random (MAR) assumption. Patient-reported and objective clinical outcomes will be compared between the two rehab groups using two sample t-test or Mann-Whitney U-test if assumptions are not met. Differences between rehab groups across the follow-up period will be identified using a repeated measures ANOVA, and the appropriate covariance structure will be determined using BIC, a measure of overall model fit. Categorical data including the proportions of complications will be compared between the two rehab groups using Chi-square or Fisher's Exact tests; odds ratios and 95% confidence limits will be calculated where appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-led rehab group | Experimental | Immobilization in arm sling for a short period time followed by patient-led shoulder exercises for rehab following reverse shoulder arthroplasty |
|
| Supervised rehab group | No Intervention | Prolonged immobilization in arm sling followed by supervised physical therapy by therapists for rehab following reverse shoulder arthroplasty |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-led rehab with short immobilization | Behavioral | Short immobilization followed by patient-led shoulder rehab |
|
| Measure | Description | Time Frame |
|---|---|---|
| American shoulder and elbow surgeons score at 6 months following surgery | American shoulder and elbow surgeons score at 6 months; lowest 0 point and highest 100 points; higher scores mean a better outcome | At 6 months following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Proportions of patients who develop any kinds of postoperative complications | During the first 2 years following surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyunmin M Kim, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26361437 | Background | Westermann RW, Pugely AJ, Martin CT, Gao Y, Wolf BR, Hettrich CM. Reverse Shoulder Arthroplasty in the United States: A Comparison of National Volume, Patient Demographics, Complications, and Surgical Indications. Iowa Orthop J. 2015;35:1-7. | |
| 25304043 | Background | Jain NB, Yamaguchi K. The contribution of reverse shoulder arthroplasty to utilization of primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Dec;23(12):1905-1912. doi: 10.1016/j.jse.2014.06.055. Epub 2014 Oct 7. |
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No plan to share IPD
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| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 25440519 | Background | Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015 Jan;24(1):91-7. doi: 10.1016/j.jse.2014.08.026. Epub 2014 Oct 29. |
| 29658976 | Background | Palsis JA, Simpson KN, Matthews JH, Traven S, Eichinger JK, Friedman RJ. Current Trends in the Use of Shoulder Arthroplasty in the United States. Orthopedics. 2018 May 1;41(3):e416-e423. doi: 10.3928/01477447-20180409-05. Epub 2018 Apr 16. |
| 18560182 | Background | Boudreau S, Boudreau ED, Higgins LD, Wilcox RB 3rd. Rehabilitation following reverse total shoulder arthroplasty. J Orthop Sports Phys Ther. 2007 Dec;37(12):734-43. doi: 10.2519/jospt.2007.2562. Epub 2007 Aug 28. |
| 31021690 | Background | Bullock GS, Garrigues GE, Ledbetter L, Kennedy J. A Systematic Review of Proposed Rehabilitation Guidelines Following Anatomic and Reverse Shoulder Arthroplasty. J Orthop Sports Phys Ther. 2019 May;49(5):337-346. doi: 10.2519/jospt.2019.8616. Epub 2019 Apr 25. |
| 29264337 | Background | Romano AM, Oliva F, Nastrucci G, Casillo P, Di Giunta A, Susanna M, Ascione F. Reverse shoulder arthroplasty patient personalized rehabilitation protocol. Preliminary results according to prognostic groups. Muscles Ligaments Tendons J. 2017 Sep 18;7(2):263-270. doi: 10.11138/mltj/2017.7.2.263. eCollection 2017 Apr-Jun. |
| 28641735 | Background | Wolff AL, Rosenzweig L. Anatomical and biomechanical framework for shoulder arthroplasty rehabilitation. J Hand Ther. 2017 Apr-Jun;30(2):167-174. doi: 10.1016/j.jht.2017.05.009. |
| 25404633 | Background | Kwaees TA, Charalambous CP. Reverse shoulder arthroplasty--minimum age for surgery, postoperative rehabilitation and long term restrictions. A delphi consensus study. Ortop Traumatol Rehabil. 2014 Jul-Aug;16(4):435-9. doi: 10.5604/15093492.1119621. |
| 24328590 | Background | Flurin PH, Marczuk Y, Janout M, Wright TW, Zuckerman J, Roche CP. Comparison of outcomes using anatomic and reverse total shoulder arthroplasty. Bull Hosp Jt Dis (2013). 2013;71 Suppl 2:101-7. |
| 19800258 | Background | Mulieri PJ, Holcomb JO, Dunning P, Pliner M, Bogle RK, Pupello D, Frankle MA. Is a formal physical therapy program necessary after total shoulder arthroplasty for osteoarthritis? J Shoulder Elbow Surg. 2010 Jun;19(4):570-9. doi: 10.1016/j.jse.2009.07.012. Epub 2009 Oct 2. |
| 24129052 | Background | Sershon RA, Van Thiel GS, Lin EC, McGill KC, Cole BJ, Verma NN, Romeo AA, Nicholson GP. Clinical outcomes of reverse total shoulder arthroplasty in patients aged younger than 60 years. J Shoulder Elbow Surg. 2014 Mar;23(3):395-400. doi: 10.1016/j.jse.2013.07.047. Epub 2013 Oct 12. |
| D000070657 |
| Crystal Arthropathies |