Status:
COMPLETED
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
Lead Sponsor:
OPKO Health, Inc.
Conditions:
ACL Reconstruction
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and v...
Eligibility Criteria
Inclusion
- Subjects aged between 18 and 55 years with partial or complete anterior cruciate ligament (ACL) rupture, diagnosed clinically and by Magnetic Resonance Imaging (MRI), requiring reconstructive surgery.
- Patients with symptoms of acute or subacute ACL rupture (such as inflammation of the knee and pain with leg movement) or chronic ACL tear, including instability of the knee.
- Patients with ACL ruptures without osteochondral lesions requiring additional surgery.
- Patients with a medical history of therapeutic benefit using analgesic agents.
Exclusion
- Patients with concomitant osteochondral pathology.
- Patients treated with intra-articular injections of corticosteroids and/or platelet-rich plasma, or with oral glucosamine, CS, HA or CH in the two months prior to surgery.
- Patients with systemic diseases, those treated with antibiotics or other drugs that might alter the healing process, and those who had undergone arthroscopic lavage in the 90 days prior to surgery.
Key Trial Info
Start Date :
March 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03355651
Start Date
March 9 2015
End Date
March 3 2017
Last Update
November 30 2017
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