Osteoarthritis of the ShoulderNCT01697865
Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction
A study testing Transfer group in people with Osteoarthritis of the Shoulder, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- Transfer group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2012to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Revision arthroplasty
- Previous shoulder infection
- Neuro-muscular disorder (ie: Parkinson's)
- Advanced dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
About this study
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
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).
- Conditions
- Osteoarthritis of the Shoulder
- Being tested
- Transfer group, Control group
- Keywords
- Reverse total shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer groupProcedure or surgery
Control groupProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transfer group | Active comparator | The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group). Receives: Procedure: Transfer group |
| Control group | Active comparator | The second technique does not include a concomitant latissimus and teres major transfer (control group). Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADLER Score
Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.
Measured: 2 Year
Secondary outcomes (5)
DASH Score
Disabilities of the Arm, Shoulder, and Hand score
Measured: 1 Year, 2 Year
ASES score
American Shoulder and Elbow Surgeons Score
Measured: 1 Year, 2 Year
SF-12 Score
General Health Outcome score
Measured: 1 Year, 2 Year
Range of Motion
Shoulder range of motion
Measured: 1 Year, 2 Year
X-Ray Measurements
X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.
Measured: 1 Year, 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start21 Jun 2012
- Primary completion12 Feb 2019
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697865
- Sponsor's protocol ID
- 061217B
- Status last verified
- Jan 2021
- First submitted
- 27 Sep 2012
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01697865
- Acronym / sponsor ID
- 061217B
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- Reverse total shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 21 Jun 2012 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfer group | Active comparator | Procedure: Transfer groupThe first surgical technique includes a concomitant latissimus and teres major transfer (transfer group). |
| Control group | Active comparator | Procedure: Control groupThe second technique does not include a concomitant latissimus and teres major transfer (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Revision arthroplasty
- Previous shoulder infection
- Neuro-muscular disorder (ie: Parkinson's)
- Advanced dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfer group | Procedure or surgery | Transfer group |
| Control group | Procedure or surgery | Control group |
Primary outcome
ADLER Score
Time frame: 2 Year
Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.
5 secondary outcomes
DASH Score
Time frame: 1 Year, 2 Year
ASES score
Time frame: 1 Year, 2 Year
SF-12 Score
Time frame: 1 Year, 2 Year
Range of Motion
Time frame: 1 Year, 2 Year
X-Ray Measurements
Time frame: 1 Year, 2 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer group in people with Osteoarthritis of the Shoulder, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADLER Score (time frame: 2 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.