Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
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|ClinicalTrials.gov Identifier: NCT03355651|
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 30, 2017
OPKO Health, Inc.
Information provided by (Responsible Party):
OPKO Health, Inc.
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.
|Condition or disease||Intervention/treatment||Phase|
|ACL Reconstruction||Dietary Supplement: PROGEN||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||ACL parasagittal cuts were performed in T1 sequences and analyzed by a blinded musculoskeletal radiologist to improve the quality of the study|
|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|
|Actual Study Start Date :||March 9, 2015|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||March 3, 2017|
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
Primary Outcome Measures :
- Pain improvement [ Time Frame: 90 days ]Assessed using a 100-mm Visual Analog Scale (VAS)
Secondary Outcome Measures :
- Knee function [ Time Frame: 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 [ Time Frame: 90 days ]Analgesic consumption and frequency of analgesic intake during follow-up
- Number of rehabilitation sessions required [ Time Frame: 90 days ]Number of required rehabilitation sessions at the end of follow-up.
- Maduration of the graft [ Time Frame: Day 0, day 90 ]Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences
Other Outcome Measures:
- Perceived efficacy and tolerability by both patients and physicians [ Time Frame: 90 days ]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
- Safety [ Time Frame: 90 days ]Assessed by means of all adverse events (AE) treatment related, reported at the end of follow-up.
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