Effect of Postop Rehab Methods on Outcomes Following Reverse Shoulder Arthroplasty

NCT04285606 | Withdrawn DMC

• 1 other identifier: 2019684MU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tear Arthropathy; Shoulder Osteoarthritis

Keywords

Reverse shoulder arthroplasty; Rehabilitation; Shoulder arthritis; Rotator cuff tear arthropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Complications

  During the first 2 years following surgery

Study Arms (2)

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

Behavioral: Patient-led rehab with short immobilization

Supervised rehab group

NO INTERVENTION

Prolonged immobilization in arm sling followed by supervised physical therapy by therapists for rehab following reverse shoulder arthroplasty

Interventions

Patient-led rehab with short immobilization BEHAVIORAL

Short immobilization followed by patient-led shoulder rehab

Patient-led rehab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Diagnosed with rotator cuff arthropathy, glenohumeral osteoarthritis with a \> 1.5-cm rotator cuff tear, or massive irreparable rotator cuff tear
• Have a normal functioning deltoid
• Have preserved teres minor function (a negative Hornblower's sign)
• Have failed conservative management for \>3 months

You may not qualify if:

• younger than 18 years
• chronic opiate use history
• fibromyalgia or other conditions that increase susceptibility to pain
• preoperative stiffness (definition: \< 30 degree passive external rotation, \< 90 degree passive forward elevation), neurologic disorder affecting the ipsilateral upper extremity,
• RTSA for acute proximal humerus fracture or fracture sequelae (nonunion, malunion)
• previous arthroplasty, fracture fixation, or open rotator cuff procedures in the same shoulder
• deltoid dysfunction
• inflammatory glenohumeral arthritis
• non-English speaking or unable to understand English for consent.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Harry S. Truman Memorial Veterans Hospital: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (12)

• 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.

  PMID: 26361437 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.

  PMID: 25304043 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.

  PMID: 25440519 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.

  PMID: 29658976 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.

  PMID: 18560182 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.

  PMID: 31021690 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.

  PMID: 29264337 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.

  PMID: 28641735 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.

  PMID: 25404633 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.

  PMID: 24328590 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.

  PMID: 19800258 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.

  PMID: 24129052 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• Hyunmin M Kim, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 26, 2020
• Study Start: July 8, 2020
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)