Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
NCT ID: NCT03355651
Last Updated: 2017-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-03-09
2017-03-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PROGEN Group
PROGEN + Standard Rehabilitation + ACL reconstruction
PROGEN
Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
Control Group
Standard Rehabilitation + ACL reconstruction
No interventions assigned to this group
Interventions
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PROGEN
Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
No
Sponsors
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OPKO Health, Inc.
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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OPK-PLA-2015-01
Identifier Type: -
Identifier Source: org_study_id