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

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

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.

Study Overview

• Status: Completed
• Conditions: ACL Reconstruction
• Intervention / Treatment: Dietary supplement: PROGEN

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PROGEN Group; PROGEN + Standard Rehabilitation + ACL reconstruction	Dietary supplement: PROGEN; Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
No Intervention: Control Group; Standard Rehabilitation + ACL reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain improvement	Assessed using a 100-mm Visual Analog Scale (VAS)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee function	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	90 days
Analgesic consumption	Analgesic consumption and frequency of analgesic intake during follow-up	90 days
Number of rehabilitation sessions required	Number of required rehabilitation sessions at the end of follow-up.	90 days
Maduration of the graft	Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences	Day 0, day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived efficacy and tolerability by both patients and physicians	Perceived efficacy and tolerability were rated by both patients and physicians on a 5-point Likert scale, where higher scores indicated better efficacy and tolerability	90 days
Safety	Assessed by means of all adverse events (AE) treatment related, reported at the end of follow-up.	90 days

Collaborators and Investigators

• Sponsor: OPKO Health, Inc.

Publications and helpful links

General Publications

• Lopez-Vidriero E, Olive-Vilas R, Lopez-Capape D, Varela-Sende L, Lopez-Vidriero R, Til-Perez L. Efficacy and Tolerability of Progen, a Nutritional Supplement Based on Innovative Plasma Proteins, in ACL Reconstruction: A Multicenter Randomized Controlled Trial. Orthop J Sports Med. 2019 Feb 27;7(2):2325967119827237. doi: 10.1177/2325967119827237. eCollection 2019 Feb.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 3, 2017

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Collagen; Chondroitin Sulfate; Dietary Supplementations; Anterior Cruciate Ligament Tears; Plasma Rich Proteins
• Other Study ID Numbers: OPK-PLA-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No