Total vs. Reverse Shoulder Replacement: Pain Relief Two Years After Surgery

NCT01884077 | Terminated Results

• 1 other identifier: 201209102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim: To compare early postoperative pain relief in patients over the age of 70 who undergo either Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty in treatment of glenohumeral osteoarthritis. Hypothesis: Early postoperative pain relief will be greater in those undergoing Reverse Shoulder Arthroplasty.

Conditions

Arthritis

Keywords

patient outcomes two years after shoulder replacement; seventy years of age and older

Outcome Measures

Primary Outcomes (2)

• ASES Score

  American Shoulder \& Elbow Survey (ASES): Assessment of patient-rated shoulder pain and function/disability. Questions involve activities of daily living that reflect the use of the shoulder \& elbow in different planes of motion. Pain and weakness with various activities are also addressed. ASES score will be calculated, compared and reported for both groups pre-operatively and 2 years post operatively: (17 patients) total arthroplasty and (17 patients) reverse arthroplasty.

  2 years after shoulder replacement

• WOOS Score

  a disease-specific quality-of-life instrument (Western Ontario Osteoarthritis of the Shoulder \[WOOS\]. WOOS Score will be generated for both groups pre-operatively and 2 years post operatively: Reverse arthroplasty(17 patients) and Total arthroplasty (17 patients) Study has been discontinued

  2 years after shoulder replacement

Secondary Outcomes (1)

• Shoulder Strength and Motion Based on Physican Examination

  2 years post shoulder replacement

Study Arms (2)

Reverse Shoulder Arthroplasty

ACTIVE COMPARATOR

Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder

Device: Total Shoulder Arthroplasty

Total Shoulder Arthroplasty

ACTIVE COMPARATOR

Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint

Device: Reverse Shoulder Arthroplasty

Interventions

Reverse Shoulder Arthroplasty DEVICE

REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).

Total Shoulder Arthroplasty

Total Shoulder Arthroplasty DEVICE

TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.

Reverse Shoulder Arthroplasty

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age 70 or older,
• have radiographic signs of osteoarthritis (narrowing of the glenohumeral joint space, marginal osteophytes around the humeral head, progressive changes with sclerosis and subcortical cystic formation and flattening of the humeral head),
• intact rotator cuff but with atrophy or fatty degeneration (defined as Grade II atrophy noted on preoperative shoulder ultrasound),
• objective weakness as measured with Isobex testing,
• limited forward elevation (less than 90 degrees)

You may not qualify if:

• patients who present with pain secondary to inflammatory arthropathy,
• obvious full-thickness rotator cuff tear,
• cuff tear arthropathy,
• revision arthroplasty,
• fracture or trauma,
• patients who had previous rotator cuff repair or prior open surgery prior to shoulder arthroplasty.
• pregnancy

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Arthroplasty, Replacement, Shoulder

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

This study was terminated due to slow enrollment and poor follow up. There is insufficient data for analysis.

Results Point of Contact

• Title: Dr. Aaron Chamberlain
• Organization: Washington University School of Medicine - Dept of Orthopaedic Surgery

chamberlaina@wudosis.wustl.edu

314-362-9283

Study Officials

• Aaron Chamberlain, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 21, 2013
• Study Start: November 1, 2012
• Primary Completion: January 28, 2015
• Study Completion: June 1, 2016
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)