Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT07257666
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Deficit Following ACL Reconstruction: PRF Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D012678', 'term': 'Sensation Disorders'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-18', 'size': 153616, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-25T04:37', 'hasProtocol': True}, {'date': '2020-09-21', 'size': 206023, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-25T04:41', 'hasProtocol': False}, {'date': '2020-09-18', 'size': 119895, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-25T04:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lysholm Knee Scoring Scale (0-100; higher scores indicate better function)', 'timeFrame': 'Baseline, 4, 8, 12 months after surgery', 'description': 'Patient-reported outcome; total score ranges from 0 (worst) to 100 (best).'}], 'primaryOutcomes': [{'measure': 'Proportion of participants without anterior knee sensory deficit at the donor site', 'timeFrame': '12 months post-surgery', 'description': 'Sensory function assessed over a predefined 9-point area lateral to the surgical scar; deficit coded as 1 if \\>3 points are reported as "no or altered touch," otherwise 0. Assessment performed with eyes closed; contralateral knee used for reference if uncertain. Measure Type \\& Units: Percentage of participants (%)'}], 'secondaryOutcomes': [{'measure': 'International Knee Documentation Committee (IKDC) Subjective Knee Form score (0-100; higher scores indicate better function)', 'timeFrame': 'Baseline, 4, 8, and 12 months post-surgery', 'description': 'Patient-reported outcome; total score ranges from 0 (worst) to 100 (best).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet-Rich Fibrin', 'ACL reconstruction', 'Bone-Patellar Tendon-Bone autograft', 'Anterior Cruciate Ligament Injury', 'Knee Surgery', 'Sensory Deficit', 'Donor Site Morbidity'], 'conditions': ['Anterior Cruciate Ligament Injury', 'Knee Injuries', 'Sensory Disorders', 'Bone-Patellar Tendon-Bone Autograft', 'Platelet-Rich Fibrin (PRF)']}, 'referencesModule': {'availIpds': [{'id': 'Ethics Committee approval No.', 'url': 'http://www.kcs.ac.rs/index.php/eticki-odbor', 'type': 'Informed Consent Form'}], 'references': [{'pmid': '35916963', 'type': 'BACKGROUND', 'citation': 'Shichman I, Baruchi D, Rachevsky G, Amzallag N, Brandstetter AS, Vidra M, Morag G. Bone filling decreases donor site morbidity after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Arch Orthop Trauma Surg. 2023 May;143(5):2565-2572. doi: 10.1007/s00402-022-04572-5. Epub 2022 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Pilot, single-center, non-randomized, parallel-group clinical study designed to assess whether intraoperative application of autologous platelet-rich fibrin (PRF) at the bone-patellar tendon-bone (BPTB) donor site reduces postoperative anterior knee sensory deficit after anterior cruciate ligament (ACL) reconstruction in competitively active male athletes. Planned enrollment is 53 participants allocated to a PRF cohort or a standard-care cohort. The primary outcome is the proportion of participants without anterior knee sensory deficit at 12 months post-surgery.', 'detailedDescription': 'Background: Sensory deficit around the BPTB donor site is a recognized complication after ACL reconstruction and may affect patient satisfaction and functional recovery. PRF is an autologous bioregenerative product with potential to support soft-tissue healing.\n\nObjective: To determine whether PRF application at the donor site reduces anterior knee sensory deficit compared with standard surgical care.\n\nDesign and Participants: Single-center, prospective, pilot, non-randomized study with two parallel cohorts (PRF vs standard care). Competitively active male athletes meeting prespecified eligibility criteria are followed at 4, 8, and 12 months post-surgery. Recruitment window: January 2022 to January 2023.\n\nInterventions: In the PRF cohort, PRF is prepared intraoperatively and applied to the donor site per manufacturer protocol; the comparator cohort receives standard closure without PRF.\n\nAssessments:\n\nPrimary outcome: Proportion of participants without anterior knee sensory deficit at 12 months. Sensory testing is performed over a predefined 9-point area lateral to the surgical scar (eyes closed; contralateral knee used as reference if uncertain).\n\nSecondary outcomes: Patient-reported knee function instruments (International Knee Documentation Committee \\[IKDC\\] Subjective Knee Form and Lysholm Knee Scoring Scale), each reported as total score (0-100; higher scores indicate better function) at 4, 8, and 12 months; optional MRI-based assessments of the donor site per protocol; safety monitoring of adverse events.\n\nAnalysis (planned): Group comparisons using appropriate categorical and non-parametric methods with prespecified approaches to handle multiplicity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing ACL reconstruction with bone-patellar tendon-bone (BPTB) autograft at the University Clinical Center of Serbia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40 years\n* Isolated anterior cruciate ligament rupture confirmed by MRI and clinical examination\n* Planned ACL reconstruction with BPTB autograft\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Previous knee surgery on the affected knee\n* Associated ligament injuries requiring additional reconstruction\n* Significant cartilage damage (Outerbridge grade III-IV beyond donor site changes)\n* Systemic disease affecting wound healing (e.g., diabetes mellitus, autoimmune disease)\n* Active infection\n* Refusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07257666', 'acronym': 'PRF-ACL', 'briefTitle': 'Sensory Deficit Following ACL Reconstruction: PRF Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'The Effect of Platelet-rich Fibrin on the Regeneration of Patellar Ligament Defects and the Functional Recovery of Patients After Anterior Cruciate Ligament Reconstruction of the Knee', 'orgStudyIdInfo': {'id': 'Eticka komisija 17/VI-3'}, 'secondaryIdInfos': [{'id': '17/VI-3', 'type': 'OTHER', 'domain': 'Ethics Committee of the Faculty of Medicine, University of Belgrade - Approval No. 17/VI-3'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRF Group', 'description': 'Patients undergoing ACL reconstruction with a bone-patellar tendon-bone (BPTB) autograft, with platelet-rich fibrin (PRF) applied at the donor site (n=24)', 'interventionNames': ['Biological: Platelet-rich fibrin (PRF)']}, {'label': 'Control Group', 'description': 'Patients undergoing ACL reconstruction with a BPTB autograft, treated with standard closure without PRF (n=29)', 'interventionNames': ['Procedure: Standard Closure (Control)']}], 'interventions': [{'name': 'Platelet-rich fibrin (PRF)', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous PRF'], 'description': "Autologous PRF prepared intraoperatively from patient's venous blood and applied at the donor site after graft harvesting.", 'armGroupLabels': ['PRF Group']}, {'name': 'Standard Closure (Control)', 'type': 'PROCEDURE', 'description': 'Conventional closure of the donor site without PRF application', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'University Clinical Center of Serbia (UKCS)', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations. Summary results will be published in peer-reviewed journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faculty of Medicine, University of Belgrade', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, University Clinical Center of Serbia, Docent, Faculty of Medicine, University of Belgrade', 'investigatorFullName': 'Darko Milovanovic', 'investigatorAffiliation': 'University of Belgrade'}}}}