Proximal Hamstring RupturePHASNCT02906865
Proximal Hamstring Avulsion Surgery Cohort Study
An observational study of Proximal Hamstring Rupture, run by Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Proximal Hamstring Rupture
- What is being tested?
- Proximal hamstring tendons repair
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Jan 2040
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Partial or complete hamstring proximal rupture
Who may be able to join
- a partial or complete hamstring proximal rupture,
- treated surgically
- diagnosis of rupture based on clinical signs and confirmed on MRI
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shahnaz Klouche, MD contact
France1 site, 1 recruiting
- Recruiting
Clinique du Sport
Paris, 75005
ShahnazKlouche, MD, klouche_shahnaz@yahoo.fr
Serge Herman, MD
About this study
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.
- Conditions
- Proximal Hamstring Rupture
- Being tested
- Proximal hamstring tendons repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal hamstring tendons repairOther
Proximal hamstring tendons repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity level
UCLA (University of California, Los Angeles ) score
Measured: 2 years
Secondary outcomes (2)
Return to sports
Yes/no
Measured: 1 year
Healing on MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startJan 2002
- Primary completionJan 2020
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Proximal Hamstring RuptureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906865
- Sponsor's protocol ID
- PHAS
- Acronym
- PHAS
- Status last verified
- Jul 2020
- First submitted
- 13 Sep 2016
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 22972314Lefevre 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.
PubMed 22926295Kassab Hassan S, Rougereau G, Moussa M, Khiami F, Gerometta A, Lefevre N, Hardy A. Development and Validation of a Short Version of the Parisian Hamstring Avulsion Score (PHAS): The Short PHAS. Orthop J Sports Med. 2026 May 18;14(5):23259671251405420. doi: 10.1177/23259671251405420. eCollection 2026 May.
PubMed 42169801Lefevre N, Moussa MK, Valentin E, Freiha K, Bohu Y, Gerometta A, Khiami F, Grimaud O, Meyer A, Hardy A. Risk Factors for Complications After Proximal Hamstring Avulsion Injury: Analysis of 757 Patients From the PHAS Cohort. Orthop J Sports Med. 2026 Mar 27;14(3):23259671261418679. doi: 10.1177/23259671261418679. eCollection 2026 Mar.
PubMed 41918719Lefevre N, Moussa MK, El Otmani L, Valentin E, Meyer A, Grimaud O, Bohu Y, Hardy A. Surgical Treatment of Proximal Hamstring Avulsion Injuries Compared With Nonsurgical Treatment: A Matched Comparative Study With a Mean Follow-up of >4 Years From the Proximal Hamstring Avulsion Surgery Cohort Study. Am J Sports Med. 2024 Sep;52(11):2718-2727. doi: 10.1177/03635465241270139. Epub 2024 Aug 21.
PubMed 39165177Lefevre N, Moussa MK, Valentin E, Meyer A, Bohu Y, Gerometta A, Khiami F, Grimaud O, Khalaf Z, Hardy A. Predictors of Early Return to Sport After Surgical Repair of Proximal Hamstring Complex Injuries in Professional Athletes: A Prospective Study. Am J Sports Med. 2024 Mar;52(4):1005-1013. doi: 10.1177/03635465231225486. Epub 2024 Feb 14.
PubMed 38353018
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Hamstring Avulsion Surgery Cohort Study
- ClinicalTrials.gov ID
- NCT02906865
- Acronym / sponsor ID
- PHAS / PHAS
- Conditions
- Proximal Hamstring Rupture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du SportUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2040 (estimated)
- First posted
- 20 Sep 2016 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Partial or complete hamstring proximal rupture
Key inclusion criteria (3 listed)
- a partial or complete hamstring proximal rupture,
- treated surgically
- diagnosis of rupture based on clinical signs and confirmed on MRI
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| Proximal hamstring tendons repairProximal hamstring tendons repair | Other | – |
Primary outcome
Activity level
Time frame: 2 years
UCLA (University of California, Los Angeles ) score
2 secondary outcomes
Return to sports
Time frame: 1 year
Healing on MRI
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Results publication: PubMed 22972314Lefevre 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.
- Results publication: PubMed 22926295Lefevre 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.
- Derived from this study: PubMed 42169801Kassab Hassan S, Rougereau G, Moussa M, Khiami F, Gerometta A, Lefevre N, Hardy A. Development and Validation of a Short Version of the Parisian Hamstring Avulsion Score (PHAS): The Short PHAS. Orthop J Sports Med. 2026 May 18;14(5):23259671251405420. doi: 10.1177/23259671251405420. eCollection 2026 May.
- Derived from this study: PubMed 41918719Lefevre N, Moussa MK, Valentin E, Freiha K, Bohu Y, Gerometta A, Khiami F, Grimaud O, Meyer A, Hardy A. Risk Factors for Complications After Proximal Hamstring Avulsion Injury: Analysis of 757 Patients From the PHAS Cohort. Orthop J Sports Med. 2026 Mar 27;14(3):23259671261418679. doi: 10.1177/23259671261418679. eCollection 2026 Mar.
- Derived from this study: PubMed 39165177Lefevre N, Moussa MK, El Otmani L, Valentin E, Meyer A, Grimaud O, Bohu Y, Hardy A. Surgical Treatment of Proximal Hamstring Avulsion Injuries Compared With Nonsurgical Treatment: A Matched Comparative Study With a Mean Follow-up of >4 Years From the Proximal Hamstring Avulsion Surgery Cohort Study. Am J Sports Med. 2024 Sep;52(11):2718-2727. doi: 10.1177/03635465241270139. Epub 2024 Aug 21.
- Derived from this study: PubMed 38353018Lefevre N, Moussa MK, Valentin E, Meyer A, Bohu Y, Gerometta A, Khiami F, Grimaud O, Khalaf Z, Hardy A. Predictors of Early Return to Sport After Surgical Repair of Proximal Hamstring Complex Injuries in Professional Athletes: A Prospective Study. Am J Sports Med. 2024 Mar;52(4):1005-1013. doi: 10.1177/03635465231225486. Epub 2024 Feb 14.
- Individual participant dataSharing planned: Undecided
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.
Shahnaz Klouche, MD contact
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 Proximal Hamstring Rupture, run by Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport at 1 site in France.
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 3 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: looking for participants now, as of the sponsor's last update on 27 Jul 2020. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahnaz Klouche, MD (klouche_shahnaz@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity level (time frame: 2 years). 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 NCT02906865, which also lists 6 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 27 Jul 2020.