Rotator Cuff TearNCT00260949
Outcome Following Surgery to Repair Rotator Cuff Tears
An observational study of Rotator Cuff Tear, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
There are two ways in which surgeons repair rotator cuff tears. An open method involves making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the skin open, while the arthroscopic method involves making small holes in the skin and using a guiding camera and special equipment to repair… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Arthroscopic repair of rotator cuff tear
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2004to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be screened by participating surgeons in a fellowship-run outpatient shoulder clinic. Patients who have consented and are scheduled to undergo an arthroscopic rotator cuff repair, and who have a cuff tear size of <5 cm, and involving 2 or fewer tendons, and meet the additional eligibility criteria will be approached to join the study.
Who may be able to join
- 1. Diagnosis of rotator cuff tear which will involve one of the following:1) history of shoulder pain or weakness 2) ability to illicit pain or weakness with one of the following signs: tenderness of the rotator cuff insertion, palpable crepitus of the subacromial bursa or a palpable defect of the cuff insertion, impingement signs and weakness of the rotator cuff musculature 3) radiological evidence of rotator cuff tear from ultrasound, arthrogram or MRI. Failed non-operative treatment. Size of tear of less than 5 cm and involving 2 or fewer tendons
Who cannot join
- Clinical:1. Tear as defined by significant muscular wasting, inability to actively forward-flex (strength grade 2/5 or worse), positive drop sign or hornblowers 2. Significant tenderness of acromioclavicular or sternoclavicular joints on affected side3. Presence of comorbid shoulder instability or evidence of SLAP lesion4. Previous surgery on affected shoulderRadiological:1. Bony abnormality on standardized series of x-rays consisting of a minimum of an antero-posterior view, lateral \“Y\” view in the scapular plane, and an axillary view.2. Presence of massive cuff tear on MRI or ultrasound (defined as \> 5 cm or greater than 2 tendons torn).Arthroscopic:1. Presence of massive cuff tear as defined above on arthroscopic examination of the joint 2. Presence of comorbid conditions: Bankart lesion, SLAP lesion3. Inability to complete the repair arthroscopically (eg. partial repair by marginal convergence without direct repair to bone)Other:Patients who have any contraindication to MRI (including claustrophobia, intracranial aneurism clip, cardiac pacemaker, middle ear prosthesis, metallic heart valve prosthesis, prior metal fragment in eye (intraocular lens implant) etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional and Anatomical Results Following Arthroscopic Cuff Repair
There are two ways in which surgeons repair rotator cuff tears. An open method involves making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the skin open, while the arthroscopic method involves making small holes in the skin and using a guiding camera and special equipment to repair the tear. This clinical study is being conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that have been repaired using the arthroscopic technique.
Read the detailed description
While many studies have researched re-tear rate for rotator cuff tears following open repair, to date there have been no studies evaluating re-tear rate following arthroscopic surgery. Arthroscopic rotator cuff repair is less invasive and exposes the patient to fewer risks than open surgery. Once this pilot study is completed the next step will be to compare the rate of re-tear, as assessed via Magnetic Resonance Imaging (MRI) between the two techniques. If the rate of re-tear is lower following arthroscopic surgery this will provide validation for use of the arthroscopic technique. If, however, the rate of re-tear is higher using the arthroscopic technique, then use of this technique is not justified.
- Conditions
- Rotator Cuff Tear
- Being tested
- Arthroscopic repair of rotator cuff tear
- Keywords
- rotator cuff tear, arthroscopic repair
- 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.
Arthroscopic repair of rotator cuff tearProcedure or surgery
Patients will undergo arthroscopic shoulder surgery in the standard fashion
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-tear at 1 year
The rate of rotator cuff re-tear will be measured 1-year post-operatively using a Magnetic Resonance Imaging (MRI) Arthrogram.
Measured: 1 year
Secondary outcomes (1)
Functional Status Anatomical integrity
Overall functional status will be assessed by the American Shoulder and Elbow Surgeons (ASES), which is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome. Functional status will also be assessed using The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points. The test is divided into four sub-categories: (1) pain (2) activities of daily living ability; (3) mobility; (4) strength. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
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 posted2 Dec 2005 (estimated)
- Study startNov 2004
- Primary completionAug 2011
- Study completionSep 2011
Why it stopped: As per advice from clinicaltrials.gov, study was mistakenly entered. Since ClinicalTrials.gov is unable to remove the record, they suggested we change the study status. Adjusting the status would eliminate the reporting requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Ottawa Hospital Research InstituteThe 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260949
- Sponsor's protocol ID
- 2003534-01H
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2005
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lapner PC, Su Y, Simon D, El-Fatori S, Lopez-Vidriero E. Does the upward migration index predict function and quality of life in arthroscopic rotator cuff repair? Clin Orthop Relat Res. 2010 Nov;468(11):3063-9. doi: 10.1007/s11999-010-1457-7. Epub 2010 Jul 7.
PubMed 20607465
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Anatomical Results Following Arthroscopic Cuff Repair
- ClinicalTrials.gov ID
- NCT00260949
- Acronym / sponsor ID
- 2003534-01H
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear, arthroscopic repair
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As per advice from clinicaltrials.gov, study was mistakenly entered. Since ClinicalTrials.gov is unable to remove the record, they suggested we change the study status. Adjusting the status would eliminate the reporting requirements.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2004 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Dec 2005 (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.
There are two ways in which surgeons repair rotator cuff tears. An open method involves making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the skin open, while the arthroscopic method involves making small holes in the skin and using a guiding camera and special equipment to repair the tear. This clinical study is being conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that have been repaired using the arthroscopic technique.
Detailed description
While many studies have researched re-tear rate for rotator cuff tears following open repair, to date there have been no studies evaluating re-tear rate following arthroscopic surgery. Arthroscopic rotator cuff repair is less invasive and exposes the patient to fewer risks than open surgery. Once this pilot study is completed the next step will be to compare the rate of re-tear, as assessed via Magnetic Resonance Imaging (MRI) between the two techniques. If the rate of re-tear is lower following arthroscopic surgery this will provide validation for use of the arthroscopic technique. If, however, the rate of re-tear is higher using the arthroscopic technique, then use of this technique is not justified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be screened by participating surgeons in a fellowship-run outpatient shoulder clinic. Patients who have consented and are scheduled to undergo an arthroscopic rotator cuff repair, and who have a cuff tear size of <5 cm, and involving 2 or fewer tendons, and meet the additional eligibility criteria will be approached to join the study.
Key inclusion criteria (1 listed)
- 1. Diagnosis of rotator cuff tear which will involve one of the following:1) history of shoulder pain or weakness 2) ability to illicit pain or weakness with one of the following signs: tenderness of the rotator cuff insertion, palpable crepitus of the subacromial bursa or a palpable defect of the cuff insertion, impingement signs and weakness of the rotator cuff musculature 3) radiological evidence of rotator cuff tear from ultrasound, arthrogram or MRI. Failed non-operative treatment. Size of tear of less than 5 cm and involving 2 or fewer tendons
Key exclusion criteria (1 listed)
- Clinical:1. Tear as defined by significant muscular wasting, inability to actively forward-flex (strength grade 2/5 or worse), positive drop sign or hornblowers 2. Significant tenderness of acromioclavicular or sternoclavicular joints on affected side3. Presence of comorbid shoulder instability or evidence of SLAP lesion4. Previous surgery on affected shoulderRadiological:1. Bony abnormality on standardized series of x-rays consisting of a minimum of an antero-posterior view, lateral \“Y\” view in the scapular plane, and an axillary view.2. Presence of massive cuff tear on MRI or ultrasound (defined as \> 5 cm or greater than 2 tendons torn).Arthroscopic:1. Presence of massive cuff tear as defined above on arthroscopic examination of the joint 2. Presence of comorbid conditions: Bankart lesion, SLAP lesion3. Inability to complete the repair arthroscopically (eg. partial repair by marginal convergence without direct repair to bone)Other:Patients who have any contraindication to MRI (including claustrophobia, intracranial aneurism clip, cardiac pacemaker, middle ear prosthesis, metallic heart valve prosthesis, prior metal fragment in eye (intraocular lens implant) etc.
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 |
|---|---|---|
| Arthroscopic repair of rotator cuff tearPatients will undergo arthroscopic shoulder surgery in the standard fashion | Procedure or surgery | – |
Primary outcome
Rate of re-tear at 1 year
Time frame: 1 year
The rate of rotator cuff re-tear will be measured 1-year post-operatively using a Magnetic Resonance Imaging (MRI) Arthrogram.
1 secondary outcome
Functional Status Anatomical integrity
Time frame: 1 year
Results and safety
The study was stopped early (reason given: As per advice from clinicaltrials.gov, study was mistakenly entered. Since ClinicalTrials.gov is unable to remove the record, they suggested we change the study status. Adjusting the status would eliminate the reporting requirements.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Results publication: PubMed 20607465Lapner PC, Su Y, Simon D, El-Fatori S, Lopez-Vidriero E. Does the upward migration index predict function and quality of life in arthroscopic rotator cuff repair? Clin Orthop Relat Res. 2010 Nov;468(11):3063-9. doi: 10.1007/s11999-010-1457-7. Epub 2010 Jul 7.
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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.
Peter Lapner principal investigator
OHRI
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 Ottawa Hospital Research Institute at 1 site in Canada.
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 1 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: stopped early, as of the sponsor's last update on 2 Jul 2025. 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 Canada. 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 was stopped early (reason given: As per advice from clinicaltrials.gov, study was mistakenly entered. Since ClinicalTrials.gov is unable to remove the record, they suggested we change the study status. Adjusting the status would eliminate the reporting requirements.). Results are not available in the source record.
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?
Rate of re-tear at 1 year (time frame: 1 year). 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 NCT00260949, which also lists 1 linked publication.
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 2 Jul 2025.