NCT02906865

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
167mo left

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2002Jan 2040

Study Start

First participant enrolled

January 1, 2002

Completed
14.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
20 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Expected
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

18 years

First QC Date

September 13, 2016

Last Update Submit

July 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Activity level

    UCLA (University of California, Los Angeles ) score

    2 years

Secondary Outcomes (2)

  • Return to sports

    1 year

  • Healing on MRI

    6 months

Interventions

Proximal hamstring tendons repair

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Partial or complete hamstring proximal rupture

You may qualify if:

  • a partial or complete hamstring proximal rupture,
  • treated surgically
  • diagnosis of rupture based on clinical signs and confirmed on MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Sport

Paris, 75005, France

RECRUITING

Related Publications (4)

  • 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.

  • Lefevre 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.

  • Lefevre 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.

Central Study Contacts

Shahnaz Klouche, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 20, 2016

Study Start

January 1, 2002

Primary Completion

January 1, 2020

Study Completion (Estimated)

January 1, 2040

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations