- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02906865
Proximal Hamstring Avulsion Surgery Cohort Study (PHAS)
July 24, 2020 updated by: Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport
Proximal hamstring rupture is a rare injury, which may be immediately diagnosed.
In 1996, Sallay showed that functional results of surgical repair were better than those of conservative treatment. Surgery is now the rule. The main aim of this study is to obtain a more detailed and quantified description of the postoperative outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shahnaz Klouche, MD
- Email: klouche_shahnaz@yahoo.fr
Study Locations
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-
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Paris, France, 75005
- Recruiting
- Clinique du Sport
-
Contact:
- ShahnazKlouche, MD
- Email: klouche_shahnaz@yahoo.fr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Partial or complete hamstring proximal rupture
Description
Inclusion Criteria:
- a partial or complete hamstring proximal rupture,
- treated surgically
- diagnosis of rupture based on clinical signs and confirmed on MRI
Exclusion Criteria:
- no exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity level
Time Frame: 2 years
|
UCLA (University of California, Los Angeles ) score
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to sports
Time Frame: 1 year
|
Yes/no
|
1 year
|
Healing on MRI
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lefevre N, Bohu Y, Naouri JF, Klouche S, Herman S. Returning to sports after surgical repair of acute proximal hamstring ruptures. Knee Surg Sports Traumatol Arthrosc. 2013 Mar;21(3):534-9. doi: 10.1007/s00167-012-2204-2. Epub 2012 Sep 13.
- Lefevre N, Bohu Y, Klouche S, Herman S. Surgical technique for repair of acute proximal hamstring tears. Orthop Traumatol Surg Res. 2013 Apr;99(2):235-40. doi: 10.1016/j.otsr.2012.05.006. Epub 2012 Aug 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
January 1, 2020
Study Completion (Anticipated)
January 1, 2040
Study Registration Dates
First Submitted
September 13, 2016
First Submitted That Met QC Criteria
September 15, 2016
First Posted (Estimate)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
July 27, 2020
Last Update Submitted That Met QC Criteria
July 24, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Proximal Hamstring Rupture
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University GhentCompletedHamstring InjuryBelgium
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Tianjin University of SportCompleted
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Clinical Trials on Proximal hamstring tendons repair
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Uppsala UniversityUniversity of Oslo; Karolinska Institutet; Lund University; University of Bergen; Umeå University and other collaboratorsCompletedHamstring Tendon InjuryNorway, Sweden
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Universidad Nacional Andres BelloUniversity of ChileCompleted
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Ain Shams UniversityActive, not recruiting