Full Thickness Rotator Cuff TearNCT03021733
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
An observational study of Full Thickness Rotator Cuff Tear, run by University of Michigan.
Trial summary
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- Operative management
- Type of treatment
- Surgery or procedure
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Nov 2016
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as determined by surgeon opinion and imaging
Who may be able to join
- Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair
Who cannot join
- less than 18 years old,
- non-operative rotator cuff tears,
- calcific tendonitis, fracture, adhesive capsulitis,
- severe osteoarthritis of the shoulder,
- no prior shoulder surgery
About this study
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.
Read the detailed description
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- Operative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative managementProcedure or surgery
Rotator cuff surgery
| Study group | Role | What they receive |
|---|---|---|
| Non-operative | Patients whom elected non-operative treatment | |
| Operative | Patients whom elected operative treatment Receives: Procedure: Operative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans Rand VR-12 Quality of Life Score
Measured: baseline
Veterans Rand VR-12 Quality of Life Score
Measured: 4 weeks
Veterans Rand VR-12 Quality of Life Score
Measured: 8 weeks
Veterans Rand VR-12 Quality of Life Score
Measured: 16 weeks
Veterans Rand VR-12 Quality of Life Score
Measured: 32 weeks
Veterans Rand VR-12 Quality of Life Score
Measured: 48 weeks
Veterans Rand VR-12 Quality of Life Score
Measured: 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startFeb 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Gagnier, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021733
- Sponsor's protocol ID
- HUM00056320
- Status last verified
- Sep 2017
- First submitted
- 12 Jan 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No individual patient data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT03021733
- Acronym / sponsor ID
- HUM00056320
- Conditions
- Full Thickness Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Jan 2017 (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.
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.
Detailed description
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-operative | – | –Patients whom elected non-operative treatment |
| Operative | – | Procedure: Operative managementPatients whom elected operative treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as determined by surgeon opinion and imaging
Key inclusion criteria (1 listed)
- Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair
Key exclusion criteria (5 listed)
- less than 18 years old,
- non-operative rotator cuff tears,
- calcific tendonitis, fracture, adhesive capsulitis,
- severe osteoarthritis of the shoulder,
- no prior shoulder surgery
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 |
|---|---|---|
| Operative managementRotator cuff surgery | Procedure or surgery | Operative |
Primary outcome
Veterans Rand VR-12 Quality of Life Score
Time frame: baseline
Veterans Rand VR-12 Quality of Life Score
Time frame: 4 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 8 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 16 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 32 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 48 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 64 weeks
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 18 Sep 2017.
- Individual participant dataSharing planned: No. No individual patient data will be shared
Related trials for Full Thickness Rotator Cuff Tear
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
RecruitingObservational study
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
Rotator Cuff Injuries
Recruiting
Cold and Compression After Rotator Cuff Repair (RCR)
High-grade Partial or Full Thickness Rotator Cuff Tears
RecruitingPhase 4
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Full Thickness Rotator Cuff Tear, run by University of Michigan.
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 1 inclusion and 5 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Veterans Rand VR-12 Quality of Life Score (time frame: baseline). The study lists 7 primary outcomes in all. 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 18 Sep 2017.