Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction
This study is currently recruiting participants.
Verified October 2012 by OrthoCarolina Research Institute, Inc.
Sponsor:
OrthoCarolina Research Institute, Inc.
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01697865
First received: September 27, 2012
Last updated: October 23, 2012
Last verified: October 2012
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Purpose
The overall objective of this study is to compare the clinical benefit and safety of two different surgical techniques of primary reverse total shoulder arthroplasty for the treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres minor dysfunction. The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group) and the second technique does not include a concomitant latissimus and teres major transfer (control group).
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis of the Shoulder |
Procedure: Transfer group Procedure: Control group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction: A Prospective, Randomized Investigation |
Resource links provided by NLM:
Further study details as provided by OrthoCarolina Research Institute, Inc.:
Primary Outcome Measures:
- ADLER Score [ Time Frame: 2 Year ] [ Designated as safety issue: No ]Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.
Secondary Outcome Measures:
- DASH Score [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]Disabilities of the Arm, Shoulder, and Hand score
- ASES score [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]American Shoulder and Elbow Surgeons Score
- SF-12 Score [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]General Health Outcome score
- Range of Motion [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]Shoulder range of motion
- X-Ray Measurements [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.
| Estimated Enrollment: | 42 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Transfer group
The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).
|
Procedure: Transfer group |
|
Active Comparator: Control group
The second technique does not include a concomitant latissimus and teres major transfer (control group).
|
Procedure: Control group |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Shoulder pseudoparalysis due to chronic rotator cuff dysfunction with or without glenohumeral arthritis.
- Chronic rotator cuff tear with severe retraction, atrophy, fatty infiltration.
- Active forward elevation of less than 90 degrees
- Teres minor dysfunction
- Positive lag and hornblower sign
- Grade 2 or greater fatty infiltration of the teres minor and infraspinatous seen on MRI
- Able to attend scheduled office visits
- Meet all criteria to have a latissimus and teres major transfer
Exclusion Criteria:
- Revision arthroplasty
- Previous shoulder infection
- Neuro-muscular disorder (ie: Parkinson's)
- Advanced dementia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697865
Contacts
| Contact: Susan M Odum, MEd | 704.323.2265 | Susan.Odum@OrthoCarolina.com |
Locations
| United States, North Carolina | |
| OrthoCarolina Research Institute | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Contact: Susan M Odum, MEd 704-323-2265 Susan.Odum@Orthocarolina.com | |
| Principal Investigator: Nady Hamid, MD | |
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
More Information
No publications provided
| Responsible Party: | OrthoCarolina Research Institute, Inc. |
| ClinicalTrials.gov Identifier: | NCT01697865 History of Changes |
| Other Study ID Numbers: | 061217B |
| Study First Received: | September 27, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by OrthoCarolina Research Institute, Inc.:
|
Reverse total shoulder |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013