Status:
ACTIVE_NOT_RECRUITING
Use of an Osteoconductive Scaffold in ACL-Reconstruction
Lead Sponsor:
Sandro Fucentese
Conditions:
ACL - Anterior Cruciate Ligament Rupture
ACL
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the ...
Detailed Description
Reconstruction of the anterior cruciate ligament (ACL) using autograft tissue is currently recommended as the standard of care following an ACL tear or rupture, with the bone-tendon-bone (BTB) graft a...
Eligibility Criteria
Inclusion
- Inclusion
- Acute unilateral complete tear of the ACL that occurred within 18 weeks before planned surgery and requires reconstruction of the
- Informed consent as documented by signature
- Exclusion Criteria:
- Prior ACL reconstruction or other surgical procedure on the affected knee.
- Prior fracture of the affected leg.
- Multi-ligament reconstruction.
- Previous or current ACL injury on contra-lateral leg.
- Medical condition or comorbidity that would interfere with study participation.
- The patient is mentally compromised.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.).
Exclusion
Key Trial Info
Start Date :
April 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03462823
Start Date
April 29 2017
End Date
December 29 2025
Last Update
August 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Balgrist University Hospital
Zurich, Switzerland, 8008