Rotator Cuff TearNCT01430598
Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
A study testing Rotator Cuff Repair and Subacromial Decompression and Questionnaire in people with Rotator Cuff Tear and Acromial Spur, run by Ascension Health at 2 sites in United States.
Trial summary
The investigators aim to establish whether completing a subacromial decompression before or after repair of a complete rotator cuff tear has any clinical significance. Both the arthroscopic decompression and rotator cuff repair will be completed during the same surgical date. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tear, Acromial Spur
- What is being tested?
- Rotator Cuff Repair and Subacromial Decompression and Questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Aug 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65
- Symptomatic patients with MRI positive full thickness rotator cuff tears
- Clinically and/or radiographically positive subacromial impingement/spur with associated rotator cuff tendonitis and bursitis
- Patients who have failed outpatient conservative therapy, including, but not limited to physical therapy and subacromial injection with steroid and local anesthetic
Who cannot join
- Patient with radiographic evidence of glenohumeral degenerative joint disease or rotator cuff arthropathy
- Patients with a prior history of joint sepsis
- Patients who have had previous shoulder surgery on the anticipated operative limb
- Patients with a diagnosed pathology causing associated pain and/or weakness to the anticipated operative limb
- Patient deemed unable to complete the post-operative rehabilitation protocol
- Patients diagnosed, either intra-operatively or by MRI, as having irreparable rotator cuff tears
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Genesys Regional Medical Center-General Surgery Center
Grand Blanc, Michigan, 48439
Stephen Nystrom, DO, 810-606-5000
Stephen Nystrom, DO
- Recruiting
Greater Flint Sports Medicine
Grand Blanc, Michigan, 48439
Stephen Nystrom, DO, 810-606-5000, stephen.nystrom@genesys.org
Stephen Nystrom, DO
About this study
Official title: Randomized Single Blinded Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
The investigators aim to establish whether completing a subacromial decompression before or after repair of a complete rotator cuff tear has any clinical significance. Both the arthroscopic decompression and rotator cuff repair will be completed during the same surgical date. The investigators null hypothesis contends that full-thickness rotator cuff tear repair performed before versus after subacromial decompression will not influence patient's post-operative pain or functionality.
Read the detailed description
All patients with a diagnosed full thickness rotator cuff tear and symptomatic subacromial decompression will be consulted about arthroscopic subacromial decompression and rotator cuff repair. The possible risks and benefits will be discussed with the patient in detail by the operating surgeon. If a patient agrees to undergo surgical intervention (i.e. arthroscopic subacromial decompression and rotator cuff repair in the same surgical setting), they will be approached and informed regarding involvement in the study. This is a single blind study so participants will not know into which arm they have been randomized.
Once consented, the subject will be randomized into one of two treatment arms. Those in Arm A will have subacromial decompression before repair of a complete rotator cuff and those in Arm B will have subacromial decompression after repair of a complete rotator cuff.
Prior to surgical intervention all patients will complete two separate questionnaires in the waiting room. The results of the questionnaires will be later used to compare pre-operative and post-operative changes following shoulder surgery.
On the date of surgery, the operative surgeon will ensure a full-thickness rotator cuff tear is present with an associated acromial spur. If both are present, the operative surgeon will perform the surgical intervention in the previously assigned order according to the patient's treatment arm. All acromial spurs will be burred to a level flush with the remaining non-pathologic acromion. The full-thickness rotator cuff will be repaired utilizing sutures and suture anchors. The specific pattern of repair will be determined intra-operatively. This is standard procedure for arthroscopic rotator cuff repair and subacromial decompression. There is no known risks within the orthopedic literature with performing subacromial decompression before versus after rotator cuff repair. As such, this study aims to identify any significance of the order of surgery if it exists.
Post-operatively all patients will be placed within a Berg SlingShot®. All patients will undergo a period of immobilization within the sling. Patients will be evaluated at 2 weeks, 6 weeks, and 12 weeks post-operatively. The shoulder range of motion and relative strength, compared to the contralateral limb, will be assessed. They will be prescribed formal physical therapy in the outpatient setting. At the 12 week visit each subject will complete the questionnaires once again. The scores will be tabulated and inserted in the Excel spreadsheet.
The pre-operative and post-operative scores will be compared. The change in score from each treatment arm will be averaged and analyzed for statistically significant difference. Also, the pre- and post-operative forward flexion, abduction range of motion will be compared. The external and internal rotation strengths will be compared from the pre- and post-operative evaluations.
- Conditions
- Rotator Cuff Tear, Acromial Spur
- Being tested
- Rotator Cuff Repair and Subacromial Decompression, Questionnaire
- Keywords
- Full Thickness Rotator Cuff Tear and Acromial Spur
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator Cuff Repair and Subacromial DecompressionProcedure or surgery
Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date.
QuestionnaireOther
Patients will be asked to complete two separate questionnaires prior to the surgical intervention. Patients will be asked to complete the same two questionnaires at 12 weeks post surgery.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Subacromial decompression before repair of a complete rotator cuff tear. Receives: Procedure: Rotator Cuff Repair and Subacromial Decompression; Other: Questionnaire |
| B | Active comparator | Subacromial decompression after repair of a complete rotator cuff repair. Receives: Procedure: Rotator Cuff Repair and Subacromial Decompression; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and Post Surgery Pain and Satisfaction
Both arms will complete an identical baseline and post-operative pain and functionality survey. The data will be analyzed to determine the rate of change between the pre and post surgery results. The results from the two groups will be compared to determine if there is a significant difference in pain and functionality between subjects in Arm A and Arm B.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Lauren Suchy, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430598
- Sponsor's protocol ID
- ME 11 0021
- Status last verified
- Sep 2011
- First submitted
- 29 Aug 2011
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single Blinded Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT01430598
- Acronym / sponsor ID
- ME 11 0021
- Conditions
- Rotator Cuff Tear, Acromial Spur
- Keywords
- Full Thickness Rotator Cuff Tear and Acromial Spur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 8 Sep 2011 (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 investigators aim to establish whether completing a subacromial decompression before or after repair of a complete rotator cuff tear has any clinical significance. Both the arthroscopic decompression and rotator cuff repair will be completed during the same surgical date. The investigators null hypothesis contends that full-thickness rotator cuff tear repair performed before versus after subacromial decompression will not influence patient's post-operative pain or functionality.
Detailed description
All patients with a diagnosed full thickness rotator cuff tear and symptomatic subacromial decompression will be consulted about arthroscopic subacromial decompression and rotator cuff repair. The possible risks and benefits will be discussed with the patient in detail by the operating surgeon. If a patient agrees to undergo surgical intervention (i.e. arthroscopic subacromial decompression and rotator cuff repair in the same surgical setting), they will be approached and informed regarding involvement in the study. This is a single blind study so participants will not know into which arm they have been randomized.
Once consented, the subject will be randomized into one of two treatment arms. Those in Arm A will have subacromial decompression before repair of a complete rotator cuff and those in Arm B will have subacromial decompression after repair of a complete rotator cuff.
Prior to surgical intervention all patients will complete two separate questionnaires in the waiting room. The results of the questionnaires will be later used to compare pre-operative and post-operative changes following shoulder surgery.
On the date of surgery, the operative surgeon will ensure a full-thickness rotator cuff tear is present with an associated acromial spur. If both are present, the operative surgeon will perform the surgical intervention in the previously assigned order according to the patient's treatment arm. All acromial spurs will be burred to a level flush with the remaining non-pathologic acromion. The full-thickness rotator cuff will be repaired utilizing sutures and suture anchors. The specific pattern of repair will be determined intra-operatively. This is standard procedure for arthroscopic rotator cuff repair and subacromial decompression. There is no known risks within the orthopedic literature with performing subacromial decompression before versus after rotator cuff repair. As such, this study aims to identify any significance of the order of surgery if it exists.
Post-operatively all patients will be placed within a Berg SlingShot®. All patients will undergo a period of immobilization within the sling. Patients will be evaluated at 2 weeks, 6 weeks, and 12 weeks post-operatively. The shoulder range of motion and relative strength, compared to the contralateral limb, will be assessed. They will be prescribed formal physical therapy in the outpatient setting. At the 12 week visit each subject will complete the questionnaires once again. The scores will be tabulated and inserted in the Excel spreadsheet.
The pre-operative and post-operative scores will be compared. The change in score from each treatment arm will be averaged and analyzed for statistically significant difference. Also, the pre- and post-operative forward flexion, abduction range of motion will be compared. The external and internal rotation strengths will be compared from the pre- and post-operative evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Rotator Cuff Repair and Subacromial Decompression, Other: QuestionnaireSubacromial decompression before repair of a complete rotator cuff tear. |
| B | Active comparator | Procedure: Rotator Cuff Repair and Subacromial Decompression, Other: QuestionnaireSubacromial decompression after repair of a complete rotator cuff repair. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65
- Symptomatic patients with MRI positive full thickness rotator cuff tears
- Clinically and/or radiographically positive subacromial impingement/spur with associated rotator cuff tendonitis and bursitis
- Patients who have failed outpatient conservative therapy, including, but not limited to physical therapy and subacromial injection with steroid and local anesthetic
Key exclusion criteria (6 listed)
- Patient with radiographic evidence of glenohumeral degenerative joint disease or rotator cuff arthropathy
- Patients with a prior history of joint sepsis
- Patients who have had previous shoulder surgery on the anticipated operative limb
- Patients with a diagnosed pathology causing associated pain and/or weakness to the anticipated operative limb
- Patient deemed unable to complete the post-operative rehabilitation protocol
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 |
|---|---|---|
| Rotator Cuff Repair and Subacromial DecompressionArthroscopic decompression and rotator cuff repair will be completed during the same surgical date. | Procedure or surgery | A, B |
| QuestionnairePatients will be asked to complete two separate questionnaires prior to the surgical intervention. Patients will be asked to complete the same two questionnaires at 12 weeks post surgery. | Other | A, B |
Primary outcome
Pre and Post Surgery Pain and Satisfaction
Time frame: 1 year
Both arms will complete an identical baseline and post-operative pain and functionality survey. The data will be analyzed to determine the rate of change between the pre and post surgery results. The results from the two groups will be compared to determine if there is a significant difference in pain and functionality between subjects in Arm A and Arm B.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator Cuff Repair and Subacromial Decompression and Questionnaire in people with Rotator Cuff Tear and Acromial Spur, run by Ascension Health at 2 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Nystrom, DO (810-606-5000, stephen.nystrom@genesys.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre and Post Surgery Pain and Satisfaction (time frame: 1 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 8 Sep 2011.