Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-10 @ 10:05 PM
Study NCT ID:
NCT03355651
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2017-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}], 'ancestors': [{'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'ACL parasagittal cuts were performed in T1 sequences and analyzed by a blinded musculoskeletal radiologist to improve the quality of the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2017-11-10', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Perceived efficacy and tolerability by both patients and physicians', 'timeFrame': '90 days', 'description': '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'}, {'measure': 'Safety', 'timeFrame': '90 days', 'description': 'Assessed by means of all adverse events (AE) treatment related, reported at the end of follow-up.'}], 'primaryOutcomes': [{'measure': 'Pain improvement', 'timeFrame': '90 days', 'description': 'Assessed using a 100-mm Visual Analog Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Knee function', 'timeFrame': '90 days', 'description': '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'}, {'measure': 'Analgesic consumption', 'timeFrame': '90 days', 'description': 'Analgesic consumption and frequency of analgesic intake during follow-up'}, {'measure': 'Number of rehabilitation sessions required', 'timeFrame': '90 days', 'description': 'Number of required rehabilitation sessions at the end of follow-up.'}, {'measure': 'Maduration of the graft', 'timeFrame': 'Day 0, day 90', 'description': 'Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament Tears', 'Dietary Supplementations', 'Plasma Rich Proteins', 'Collagen', 'Chondroitin Sulfate', 'Hyaluronic Acid'], 'conditions': ['ACL Reconstruction']}, 'referencesModule': {'references': [{'pmid': '30834280', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* Patients with ACL ruptures without osteochondral lesions requiring additional surgery.\n* Patients with a medical history of therapeutic benefit using analgesic agents.\n\nExclusion Criteria:\n\n* Patients with concomitant osteochondral pathology.\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT03355651', 'briefTitle': 'Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction', 'organization': {'class': 'INDUSTRY', 'fullName': 'OPKO Health, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OPK-PLA-2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PROGEN Group', 'description': 'PROGEN + Standard Rehabilitation + ACL reconstruction', 'interventionNames': ['Dietary Supplement: PROGEN']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Standard Rehabilitation + ACL reconstruction'}], 'interventions': [{'name': 'PROGEN', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C', 'armGroupLabels': ['PROGEN Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OPKO Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}