Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction

OPKO Health

Status

Completed

Conditions

ACL Reconstruction

Treatments

Dietary Supplement: PROGEN

Study type

Interventional

Funder types

Industry

Identifiers

NCT03355651

OPK-PLA-2015-01

Details and patient eligibility

About

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 vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.

Enrollment

80 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.