Rotator Cuff TearNCT00891566
Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact
An observational study of Rotator Cuff Tear, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff. The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Immobilization
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Apr 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: medium to large size rotator cuff tears
Who may be able to join
- Medium to large sized cuff tear (2-4 cm)
- Yes subscapular partial fraying or longitudinal split side to side
- Yes acromioplasty
- Yes AC arthritis with mumford procedure
- Yes biceps tenotomy or tenodesis
Who cannot join
- No arthritic changes of glenohumeral joint
- No combined infection
- No mini-open procedures
- No complete subscapularis tear
- No incomplete repair
- No small tears or side to side repairs without anchors
- No pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial
The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.
The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.
- Conditions
- Rotator Cuff Tear
- Being tested
- Immobilization
- Keywords
- medium to large tear, rotator cuff tear, arthroscopic repair, repair integrity, immobilization
- 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.
ImmobilizationProcedure or surgery
compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair
What is being measured
The primary outcome is the main question the study is designed to answer.
repair integrity analysis using postoperative MRI
Measured: 6 months
Secondary outcomes (1)
American Shoulder and Elbow Surgeons' score
Measured: 2 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891566
- Sponsor's protocol ID
- 2008-04-051
- Status last verified
- May 2011
- First submitted
- 29 Apr 2009
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pennekamp W, Gekle C, Nicolas V, Seybold D. [Initial results of shoulder MRI in external rotation after primary shoulder dislocation and after immobilization in external rotation]. Rofo. 2006 Apr;178(4):410-5. doi: 10.1055/s-2006-926476. German.
PubMed 16607589Lewis CW, Schlegel TF, Hawkins RJ, James SP, Turner AS. The effect of immobilization on rotator cuff healing using modified Mason-Allen stitches: a biomechanical study in sheep. Biomed Sci Instrum. 2001;37:263-8.
PubMed 11347400Kim SH, Yoo JC, Ahn JM. Arthroscopically repaired Bankart lesions and the effect of two different arm positions on immediate postoperative evaluation with magnetic resonance arthrography. Arthroscopy. 2005 Jul;21(7):867-74. doi: 10.1016/j.arthro.2005.04.109.
PubMed 16012501Koh KH, Lim TK, Shon MS, Park YE, Lee SW, Yoo JC. Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization. J Bone Joint Surg Am. 2014 Mar 19;96(6):e44. doi: 10.2106/JBJS.L.01741.
PubMed 24647511
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00891566
- Acronym / sponsor ID
- 2008-04-051
- Conditions
- Rotator Cuff Tear
- Keywords
- medium to large tear, rotator cuff tear, arthroscopic repair, repair integrity, immobilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 May 2009 (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 purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.
The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- medium to large size rotator cuff tears
Key inclusion criteria (5 listed)
- Medium to large sized cuff tear (2-4 cm)
- Yes subscapular partial fraying or longitudinal split side to side
- Yes acromioplasty
- Yes AC arthritis with mumford procedure
- Yes biceps tenotomy or tenodesis
Key exclusion criteria (7 listed)
- No arthritic changes of glenohumeral joint
- No combined infection
- No mini-open procedures
- No complete subscapularis tear
- No incomplete repair
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 |
|---|---|---|
| Immobilizationcompared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair | Procedure or surgery | – |
Primary outcome
repair integrity analysis using postoperative MRI
Time frame: 6 months
1 secondary outcome
American Shoulder and Elbow Surgeons' score
Time frame: 2 year postoperatively
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 24 May 2011.
- Results publication: PubMed 16607589Pennekamp W, Gekle C, Nicolas V, Seybold D. [Initial results of shoulder MRI in external rotation after primary shoulder dislocation and after immobilization in external rotation]. Rofo. 2006 Apr;178(4):410-5. doi: 10.1055/s-2006-926476. German.
- Results publication: PubMed 11347400Lewis CW, Schlegel TF, Hawkins RJ, James SP, Turner AS. The effect of immobilization on rotator cuff healing using modified Mason-Allen stitches: a biomechanical study in sheep. Biomed Sci Instrum. 2001;37:263-8.
- Results publication: PubMed 16012501Kim SH, Yoo JC, Ahn JM. Arthroscopically repaired Bankart lesions and the effect of two different arm positions on immediate postoperative evaluation with magnetic resonance arthrography. Arthroscopy. 2005 Jul;21(7):867-74. doi: 10.1016/j.arthro.2005.04.109.
- Derived from this study: PubMed 24647511Koh KH, Lim TK, Shon MS, Park YE, Lee SW, Yoo JC. Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization. J Bone Joint Surg Am. 2014 Mar 19;96(6):e44. doi: 10.2106/JBJS.L.01741.
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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?
An observational study of Rotator Cuff Tear, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 7 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 24 May 2011. 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 South Korea. 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?
repair integrity analysis using postoperative MRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00891566, which also lists 4 linked publications.
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 24 May 2011.