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

ACL Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355651
• Other study ID #: OPK-PLA-2015-01
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 28, 2017
• Start date: March 9, 2015
• Est. completion date: March 3, 2017

Study information

• Verified date: November 2017
• Source: Opko Health Spain, S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 3, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL Reconstruction

Intervention

Dietary Supplement:
• PROGEN
Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Opko Health Spain, S.L.U.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Safety	Assessed by means of all adverse events (AE) treatment related, reported at the end of follow-up.	90 days
Primary	Pain improvement	Assessed using a 100-mm Visual Analog Scale (VAS)	90 days
Secondary	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
Secondary	Analgesic consumption	Analgesic consumption and frequency of analgesic intake during follow-up	90 days
Secondary	Number of rehabilitation sessions required	Number of required rehabilitation sessions at the end of follow-up.	90 days
Secondary	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