Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction: Patella, Hamstrings or Quadriceps Tendon Autograft

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current gold Standard treatment for young and active patients with instability, is a surgical ACL reconstruction. However, there still is no consensus on which graft is best suited for this.The aim of the current multi-center randomized controlled trial was to investigate the hypothesis that an anatomic single bundle anterior cruciate ligament reconstruction with a (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured anterior cruciate ligament with a patella tendon autograft or a hamstringtendon autograft, in terms of failure, measured 2 years postoperatively. Failure is defined gedefinieerd as pathologicai laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty ofthe graft on MRl or arthroscopy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients active in sports, Tegner =/\>5

• Primary ACL rupture, evident from anamnesis (acute trauma, snapping sensation, swelling within several hours, feeling of instability), physical examination (positive Lachman test, anterior drawertest and/or pivot shift test), radiograph and MRl

• Willing to comply to the suggested (nationwide standard) rehabilitation protocol, supen/ised by a NFVS registerd sport-physical therapist

• \<6 months between initial trauma and surgery

Locations
Other Locations
Netherlands
Martini Hospital Groningen
NOT_YET_RECRUITING
Groningen
OCON
RECRUITING
Hengelo
Contact Information
Primary
R.A.G Hoogeslag, MD
wetenschap@ocon.nl
0031887085375
Time Frame
Start Date: 2017-03-06
Estimated Completion Date: 2029-12
Participants
Target number of participants: 439
Treatments
Active_comparator: Hamstring tendon autograft
ACL reconstruction surgery with hamstring tendon autograft
Active_comparator: Patella tendon autograft
ACL reconstruction surgery with pattella tendon autograft
Active_comparator: Quadriceps tendon autograft
ACL reconstruction surgery with quadriceps tendon autograft
Related Therapeutic Areas
Sponsors
Collaborators: Martini Hospital Groningen, Gelderse Vallei Hospital
Leads: Orthopedisch Centrum Oost Nederland

This content was sourced from clinicaltrials.gov

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