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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02906865
Other study ID # PHAS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2002
Est. completion date January 2040

Study information

Verified date July 2020
Source Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport
Contact Shahnaz Klouche, MD
Email klouche_shahnaz@yahoo.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. The main aim of this study is to obtain a more detailed and quantified description of the postoperative outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date January 2040
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Proximal hamstring tendons repair
Proximal hamstring tendons repair

Locations

Country Name City State
France Clinique du Sport Paris

Sponsors (1)

Lead Sponsor Collaborator
Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Activity level UCLA (University of California, Los Angeles ) score 2 years
Secondary Return to sports Yes/no 1 year
Secondary Healing on MRI 6 months