NCT03430167

Brief Summary

The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

January 23, 2018

Last Update Submit

March 22, 2023

Conditions

Shoulder Arthropathy Associated With Other Conditions

Keywords

Reverse Total Shoulder Arthroplastypost operative physical therapy

Outcome Measures

Primary Outcomes (1)

  • Range of Motion Outcomes

    Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.

    Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively

Secondary Outcomes (3)

  • Clinical Outcome Scores - Quality of Life

    Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively

  • Clinical Outcome Scores - Functional

    Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively

  • Clinical Outcome Scores - Pain

    Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively

Study Arms (2)

Group I - Formal Therapy

OTHER

Supervised physical therapy will be ordered 2 times/week initially for 6 weeks and then tailored to a minimum of 1 visit/week based upon the individual progress of each patient. Home exercises will be provided to the patient by the therapist to be performed daily. Supervised physical therapy will be discontinued once the patient demonstrates independence with the final phase of rehabilitation, which represents the graduated strengthening program.

Other: formal therapy

Group II - Home Therapy

OTHER

In the study group all patients will be instructed in a standardized fashion regarding a home exercise program. This program will involve a standardized a set of five exercises. These exercises will be reviewed with patients in clinic in a standardized fashion and patients will be provided with an instructive hand-out.

Other: home therapy

Interventions

home therapyOTHER

Patients will be given a set of instructions for completing home therapy for range of motion and strengthening

Group II - Home Therapy
formal therapyOTHER

Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises

Group I - Formal Therapy

Eligibility Criteria

Age61 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
  • A pre-operative plan for RTSA
  • Age \>60

You may not qualify if:

  • Active infection
  • Incompetent deltoid muscle
  • Unwillingness or inability to participate in a home exercise program
  • Medically unfit for operative intervention
  • Revision RTSA
  • RTSA for glenohumeral osteoarthritis or proximal humerus fracture
  • Unwillingness to participate in the study
  • Inability to read or comprehend written instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah - Orthopedics

Salt Lake City, Utah, 84108, United States

Location

Related Publications (23)

  • Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011 Dec 21;93(24):2249-54. doi: 10.2106/JBJS.J.01994.

    PMID: 22258770BACKGROUND

  • 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: 25440519BACKGROUND

  • Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012 Nov;21(11):1464-9. doi: 10.1016/j.jse.2011.11.012. Epub 2012 Feb 22.

    PMID: 22365817BACKGROUND

  • Young SW, Zhu M, Walker CG, Poon PC. Comparison of functional outcomes of reverse shoulder arthroplasty with those of hemiarthroplasty in the treatment of cuff-tear arthropathy: a matched-pair analysis. J Bone Joint Surg Am. 2013 May 15;95(10):910-5. doi: 10.2106/JBJS.L.00302.

    PMID: 23677358BACKGROUND

  • Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006 Aug;88(8):1742-7. doi: 10.2106/JBJS.E.00851.

    PMID: 16882896BACKGROUND

  • Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010 Nov 3;92(15):2544-56. doi: 10.2106/JBJS.I.00912.

    PMID: 21048173BACKGROUND

  • Steen BM, Cabezas AF, Santoni BG, Hussey MM, Cusick MC, Kumar AG, Frankle MA. Outcome and value of reverse shoulder arthroplasty for treatment of glenohumeral osteoarthritis: a matched cohort. J Shoulder Elbow Surg. 2015 Sep;24(9):1433-41. doi: 10.1016/j.jse.2015.01.005. Epub 2015 Mar 11.

    PMID: 25769903BACKGROUND

  • Wall B, Nove-Josserand L, O'Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007 Jul;89(7):1476-85. doi: 10.2106/JBJS.F.00666.

    PMID: 17606786BACKGROUND

  • Favard L, Levigne C, Nerot C, Gerber C, De Wilde L, Mole D. Reverse prostheses in arthropathies with cuff tear: are survivorship and function maintained over time? Clin Orthop Relat Res. 2011 Sep;469(9):2469-75. doi: 10.1007/s11999-011-1833-y.

    PMID: 21384212BACKGROUND

  • Kiet TK, Feeley BT, Naimark M, Gajiu T, Hall SL, Chung TT, Ma CB. Outcomes after shoulder replacement: comparison between reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Feb;24(2):179-85. doi: 10.1016/j.jse.2014.06.039. Epub 2014 Sep 9.

    PMID: 25213827BACKGROUND

  • Cazeneuve JF, Cristofari DJ. The reverse shoulder prosthesis in the treatment of fractures of the proximal humerus in the elderly. J Bone Joint Surg Br. 2010 Apr;92(4):535-9. doi: 10.1302/0301-620X.92B4.22450.

    PMID: 20357330BACKGROUND

  • Levy JC, Badman B. Reverse shoulder prosthesis for acute four-part fracture: tuberosity fixation using a horseshoe graft. J Orthop Trauma. 2011 May;25(5):318-24. doi: 10.1097/BOT.0b013e3181f22088.

    PMID: 21464740BACKGROUND

  • Frankle M, Siegal S, Pupello D, Saleem A, Mighell M, Vasey M. The Reverse Shoulder Prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients. J Bone Joint Surg Am. 2005 Aug;87(8):1697-705. doi: 10.2106/JBJS.D.02813.

    PMID: 16085607BACKGROUND

  • Chalmers PN, Slikker W 3rd, Mall NA, Gupta AK, Rahman Z, Enriquez D, Nicholson GP. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014 Feb;23(2):197-204. doi: 10.1016/j.jse.2013.07.044. Epub 2013 Sep 27.

    PMID: 24076000BACKGROUND

  • Cvetanovich GL, Chalmers PN, Streit JJ, Romeo AA, Nicholson GP. Patients Undergoing Total Shoulder Arthroplasty on the Dominant Extremity Attain Greater Postoperative ROM. Clin Orthop Relat Res. 2015 Oct;473(10):3221-5. doi: 10.1007/s11999-015-4400-0. Epub 2015 Jun 12.

    PMID: 26066068BACKGROUND

  • Levy JC, Everding NG, Gil CC Jr, Stephens S, Giveans MR. Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Dec;23(12):1872-1881. doi: 10.1016/j.jse.2014.04.014. Epub 2014 Jun 26.

    PMID: 24981553BACKGROUND

  • Young AA, Smith MM, Bacle G, Moraga C, Walch G. Early results of reverse shoulder arthroplasty in patients with rheumatoid arthritis. J Bone Joint Surg Am. 2011 Oct 19;93(20):1915-23. doi: 10.2106/JBJS.J.00300.

    PMID: 22012529BACKGROUND

  • Hattrup SJ, Sanchez-Sotelo J, Sperling JW, Cofield RH. Reverse shoulder replacement for patients with inflammatory arthritis. J Hand Surg Am. 2012 Sep;37(9):1888-94. doi: 10.1016/j.jhsa.2012.05.015. Epub 2012 Jun 30.

    PMID: 22749484BACKGROUND

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PMID: 3558716BACKGROUND

  • Charlson ME, Sax FL, MacKenzie CR, Braham RL, Fields SD, Douglas RG Jr. Morbidity during hospitalization: can we predict it? J Chronic Dis. 1987;40(7):705-12. doi: 10.1016/0021-9681(87)90107-x.

    PMID: 3110198BACKGROUND

  • Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2.

    PMID: 10512449BACKGROUND

  • Kappe T, Cakir B, Reichel H, Elsharkawi M. Reliability of radiologic classification for cuff tear arthropathy. J Shoulder Elbow Surg. 2011 Jun;20(4):543-7. doi: 10.1016/j.jse.2011.01.012. Epub 2011 Mar 30.

    PMID: 21454101BACKGROUND

  • Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Mole D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004 Apr;86(3):388-95. doi: 10.1302/0301-620x.86b3.14024.

    PMID: 15125127BACKGROUND

MeSH Terms

Interventions

Home Infusion Therapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsHome Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Aaron Chamberlain, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
post operative assessor obtaining range of motion and performing physical exam will be blinded to participant's group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 12, 2018

Study Start

January 29, 2018

Primary Completion

January 12, 2023

Study Completion

January 12, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)