Effect of Postop Rehab Methods on Outcomes Following Reverse Shoulder Arthroplasty

November 16, 2022 updated by: H. Mike Kim, University of Missouri-Columbia

Effect of Different Postoperative Rehab Methods on Clinical Outcomes Following Reverse Shoulder Arthroplasty: A Prospective Randomized Clinical Trial Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

  1. Patient-led rehab group Duration of the sling: 1 week in sling with abduction pillow for immobilization; then optional for comfort only Start of shoulder exercise: Within 1 week of surgery once pain subsides Mode of rehab: Patients performing exercises on their own following instructions Phase 1 (3-5 days to 2 weeks): Pendulum, deltoid and periscapular muscle isometric strengthening Phase 2 (2-4 weeks): passive, active assisted motion Phase 3 (4-8 weeks): Active motion Phase 4 (8-12 weeks): Strengthening
  2. Supervised rehab group Duration of the sling: 4 weeks in sling with abduction pillow for immobilization; then optional for comfort only Start of shoulder exercise: At 4 weeks after surgery Mode of rehab: Patients attending outpatient physical therapy sessions led by therapists Phase 1 (0-4 weeks): Immobilization in sling Phase 2 (4-8 weeks): Passive, active assisted motion Phase 3 (8-12 weeks): Active motin Phase 4 (12-16 weeks): Strengthening

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.

  1. Pain measured using a visual analog scale daily for the first 2 weeks; then at each follow-up visit
  2. Patient-reported outcomes: ASES, QuickDASH, SANE, and PROMIS at each visit except at 2 weeks.
  3. Range of motion: forward elevation, external rotation, internal rotation at each visit except at 2 weeks
  4. Radiographic findings of failure such as dislocation, implant dislodgement, migration, or loosening, scapular notching, periprosthetic humuerus fracture, or scapular fracture at any time: Will be included as complications
  5. Complications such as instability, hematoma, wound healing issue, abnormal level of pain due to rehab method at any time, or reoperation
  6. Overall patient satisfaction with their rehab method using a 5-point Likert-type scale at 6 months (Question: Were you satisfied with your rehab method? Very unsatisfied, slightly unsatisfied, neutral, somewhat satisfied, very satisfied)

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient-led rehab group
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
Short immobilization followed by patient-led shoulder rehab
No Intervention: Supervised rehab group
Prolonged immobilization in arm sling followed by supervised physical therapy by therapists for rehab following reverse shoulder arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American shoulder and elbow surgeons score at 6 months following surgery
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: During the first 2 years following surgery
Proportions of patients who develop any kinds of postoperative complications
During the first 2 years following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

Harry S. Truman Memorial Veterans Hospital

Investigators

  • Principal Investigator: Hyunmin M Kim, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2020

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019684MU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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