Prospective Study for Assess Efficacy and Tolerability of an Oral Supplement Based on Collagen, HC-15 and Plasmatic Proteins, in the Recovery of ACL After Surgery: a Multicenter, Randomized, Controlled Trial

OPKO Health, Inc.0 sites80 target enrollmentMarch 9, 2015

ConditionsACL Reconstruction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ACL Reconstruction
Sponsor: OPKO Health, Inc.
Enrollment: 80
Primary Endpoint: Pain improvement
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 9, 2015

End Date

March 3, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OPKO Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.