Rotator CuffNCT00739947
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
An observational study of Rotator Cuff and Arthroscopic Surgery, run by Pfizer at 37 sites in United States.
Trial summary
This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Rotator Cuff, Arthroscopic Surgery
- What is being tested?
- Observational study of the surgical outcome
- How many people
- 162 participants
- Where
- 37 sitesUnited States
- Study dates
- 13 Oct 2008to 5 Jul 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.
- Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy
Who cannot join
- Previous surgical intervention to the shoulder joint understudy
- Tears of the subscapularis or labral pathology requiring surgical repair
- Shoulder instability either shoulder
- Unable to complete functional evaluations in either shoulder
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Texas Orthopedic Specialists, PA
Bedford, Texas, 76021
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Everett Clinic
Everett, Washington, 98201
Orthopedic Specialists
Grapevine, Texas, 76051
Preferred Imaging
Grapevine, Texas, 76051
Kelsey Research Foundation
Houston, Texas, 77005
Kelsey-Seybold Spring Medical and Diagnostic Center
Houston, Texas, 77014
Kelsey Seybold Clinic
Houston, Texas, 77025
St. Luke's Episcopal Hospital
Houston, Texas, 77030
Yale University School of Medicine
New Haven, Connecticut, 06510
Yale-New Haven Hospital
New Haven, Connecticut, 06520
Hospital for Special Surgery
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
The Core Institute
Phoenix, Arizona, 85027
Desert Valley Radiology
Phoenix, Arizona, 85032
Paradise Valley Hospital
Phoenix, Arizona, 85032
Desert Valley Radiology
Phoenix, Arizona, 85037
University Orthopedics
Providence, Rhode Island, 02905
University Orthopedics, Inc.
Providence, Rhode Island, 02906
University of Rochester Medical Center
Rochester, New York, 14618
University Orthopaedic Associates
Rochester, New York, 14618
University of Rochester Medical Center
Rochester, New York, 14642
University of California, San Francisco
San Francisco, California, 94115
University of California, San Francisco
San Francisco, California, 94120
University of California, San Francisco
San Francisco, California, 94143-0728
University of California, San Francisco
San Francisco, California, 94143
University of California, San Francisco
San Francisco, California, 94158
Harris Methodist Southlake
Southlake, Texas, 76092
Banner Boswell Imaging Center
Sun City, Arizona, 85351
Banner Boswell Medical Center
Sun City, Arizona, 85351
The Core Institute
Sun City, Arizona, 85351
Banner Del E Webb Medical Center
Sun City West, Arizona, 85375
Banner Del E Webb Outpatient Diagnostics
Sun City West, Arizona, 85375
The CORE Institute-Sun City West
Sun City West, Arizona, 85375
Massachusetts General Hospital
Waltham, Massachusetts, 02451
About this study
Official title: A PROSPECTIVE STUDY TO EVALUATE SURGICAL OUTCOMES IN SUBJECTS WITH FULL-THICKNESS ROTATOR CUFF TEARS TREATED BY MEANS OF A DOUBLE-ROW ARTHROSCOPIC REPAIR.
This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.
Read the detailed description
Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.
- Conditions
- Rotator Cuff, Arthroscopic Surgery
- Being tested
- Observational study of the surgical outcome
- Keywords
- Observational, rotator cuff tear, arthroscopic, surgical, outcome study
- 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.
Observational study of the surgical outcomeOther
Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Standard of Care Receives: Other: Observational study of the surgical outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery.
Measured: 1 year
Secondary outcomes (5)
Determine the correlation of functional outcomes over time in subjects with retears compared with subjects who have an intact cuff repair using the Constant Murley Shoulder Score as well as strength and range of motion.
Measured: 1 year
Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function).
Measured: 1 year
Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes.
Measured: 1 year
Evaluation of the ability to define
Measured: 1 year
Observation of any comorbidity associated with the arthroscopic surgical procedure through the collection of adverse events to provide and SOC reference for future safety studies.
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 posted22 Aug 2008 (estimated)
- Study start13 Oct 2008
- Primary completion5 Jul 2011
- Study completion5 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator CuffStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739947
- Sponsor's protocol ID
- 3202V1-1000
- Other IDs
- B1861001
- Status last verified
- Feb 2021
- First submitted
- 21 Aug 2008
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE STUDY TO EVALUATE SURGICAL OUTCOMES IN SUBJECTS WITH FULL-THICKNESS ROTATOR CUFF TEARS TREATED BY MEANS OF A DOUBLE-ROW ARTHROSCOPIC REPAIR.
- ClinicalTrials.gov ID
- NCT00739947
- Acronym / sponsor ID
- 3202V1-1000
- Conditions
- Rotator Cuff, Arthroscopic Surgery
- Keywords
- Observational, rotator cuff tear, arthroscopic, surgical, outcome study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2008 (actual)
- Primary completion
- 5 Jul 2011 (actual)
- Study completion
- 5 Jul 2011 (actual)
- First posted
- 22 Aug 2008 (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 is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.
Detailed description
Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Observational study of the surgical outcomeStandard of Care |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (2 listed)
- Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.
- Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy
Key exclusion criteria (4 listed)
- Previous surgical intervention to the shoulder joint understudy
- Tears of the subscapularis or labral pathology requiring surgical repair
- Shoulder instability either shoulder
- Unable to complete functional evaluations in either shoulder
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 |
|---|---|---|
| Observational study of the surgical outcomeSubjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound. | Other | 1 |
Primary outcome
The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery.
Time frame: 1 year
5 secondary outcomes
Determine the correlation of functional outcomes over time in subjects with retears compared with subjects who have an intact cuff repair using the Constant Murley Shoulder Score as well as strength and range of motion.
Time frame: 1 year
Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function).
Time frame: 1 year
Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes.
Time frame: 1 year
Evaluation of the ability to define
Time frame: 1 year
Observation of any comorbidity associated with the arthroscopic surgical procedure through the collection of adverse events to provide and SOC reference for future safety studies.
Time frame: 1 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 16 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
37 sites 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 and Arthroscopic Surgery, run by Pfizer at 37 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 2 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
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?
The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery. (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 16 Feb 2021.