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

Not Applicable

Completed

• Conditions: ACL Reconstruction
• Interventions: Dietary Supplement: PROGEN

• Registration Number: NCT03355651
• Lead Sponsor: OPKO Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-09
• Primary Completion: 2017-02-01
• Study Completion: 2017-03-03
• Status Verified: 2017-11
• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-28
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PROGEN Group	PROGEN	PROGEN + Standard Rehabilitation + ACL reconstruction

Primary Outcome Measures

Name	Time	Method
Pain improvement	90 days	Assessed using a 100-mm Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Number of rehabilitation sessions required	90 days	Number of required rehabilitation sessions at the end of follow-up.
Maduration of the graft	Day 0, day 90	Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences
Knee function	90 days	Assessed using the International Knee Documentation Committee (IKDC) index. The final score was interpreted as a measure of function, with higher scores representing higher levels of function
Analgesic consumption	90 days	Analgesic consumption and frequency of analgesic intake during follow-up