Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 3:28 AM
Study NCT ID:
NCT07470359
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma Injection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS4 score', 'timeFrame': '12 months', 'description': 'To compare knee-related functional outcomes, as measured by the KOOS4 score, between patients undergoing arthroscopic ACL reconstruction with peroneus longus autograft and intra-articular PRP injection versus those undergoing ACL reconstruction with peroneus longus autograft alone at 3-, 6-, and 12-months post-surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament, ACL Reconstruction, Peroneus Longus Autograft, Platelet-Rich Plasma, Intra-articular Injection', 'Randomized Controlled Trial, KOOS4 Score, Functional Outcomes, Graft Healing, Resource-Limited Settings'], 'conditions': ['ACL Reconstruction', 'Intraarticular Injection', 'PRP']}, 'referencesModule': {'references': [{'pmid': '35155701', 'type': 'BACKGROUND', 'citation': 'Kunze KN, Pakanati JJ, Vadhera AS, Polce EM, Williams BT, Parvaresh KC, Chahla J. The Efficacy of Platelet-Rich Plasma for Ligament Injuries: A Systematic Review of Basic Science Literature With Protocol Quality Assessment. Orthop J Sports Med. 2022 Feb 9;10(2):23259671211066504. doi: 10.1177/23259671211066504. eCollection 2022 Feb.'}, {'pmid': '35103026', 'type': 'BACKGROUND', 'citation': 'Gong H, Huang B, Zheng Z, Fu L, Chen L. Clinical Use of Platelet-Rich Plasma to Promote Tendon-Bone Healing and Graft Maturation in Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Study. Indian J Orthop. 2022 Jan 27;56(5):805-811. doi: 10.1007/s43465-021-00533-z. eCollection 2022 May.'}, {'pmid': '36056588', 'type': 'BACKGROUND', 'citation': 'Cao Y, Wan YD. Effectiveness of Platelet-Rich Plasma in Anterior Cruciate Ligament Reconstruction: A Systematic Review of Randomized Controlled Trials. Orthop Surg. 2022 Oct;14(10):2406-2417. doi: 10.1111/os.13279. Epub 2022 Sep 2.'}], 'seeAlsoLinks': [{'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC8811441/', 'label': 'Pmc.ncbi'}]}, 'descriptionModule': {'briefSummary': "This prospective RCT investigates if a single 4 ml intra-articular PRP injection improves knee function after ACL reconstruction using peroneus longus autograft. In Pakistan's resource-limited context, 88 patients (18-50 years) with isolated ACL tears receive either PRP or saline during surgery, then randomized equally. KOOS4 scores compared at 3, 6, and 12 months via ANCOVA (adjusted baseline, α=0.05). Positive results could establish affordable enhancement for recovery and guide practice in similar settings.", 'detailedDescription': 'Anterior cruciate ligament (ACL) injuries impair knee function, particularly in young athletes, with many failing to regain pre-injury performance post-reconstruction (ACLR). Peroneus longus autografts offer comparable strength to traditional grafts with reduced donor site morbidity, but early recovery remains challenging. Platelet-rich plasma (PRP) may enhance graft healing, yet its efficacy with peroneus longus autografts is understudied, especially in resource-limited settings like Pakistan, where costly PRP methods are impractical. This prospective randomized controlled trial (RCT) evaluates whether a single intra-articular PRP injection (4 ml, 2 ml per femoral/tibial tunnel) improves functional outcomes in ACLR with peroneus longus autograft. The hypothesis is that PRP will lead to superior knee functions. The study aims to compare KOOS4 scores at 3, 6, and 12 months between PRP and control groups. Eighty-eight patients (44 per group) aged 18-50 with isolated ACL tears will be randomized (1:1) to receive 4 ml PRP (from 15-20 ml blood, single-spin centrifugation at 3500 rpm) or saline during surgery at Lahore General Hospital. Assessments at baseline, 3, 6, and 12 months will use validated KOOS4 questionnaires, integrated into clinic visits to ensure low dropout (10%). Data will be analyzed using analysis of covariance (ANCOVA) for KOOS4 scores (α = 0.05) in SPSS, adjusting for baseline differences. Improved KOOS4 scores with PRP could validate a cost-effective approach, enhance recovery and inform clinical guidelines in resource-constrained settings, ultimately improving patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Age between 18 and 50 years. Diagnosis of a primary, complete ACL tear requiring reconstruction. Willingness to undergo arthroscopic ACL reconstruction with peroneus longus autograft.\n\nActive individuals participating in sports or regular physical activity. Willingness to provide informed consent and adhere to the study protocol, including follow-up visits and rehabilitation.\n\nAbility to understand and complete study questionnaires. - Exclusion Criteria: Previous knee surgery on the affected limb. Concomitant ligamentous injuries requiring additional reconstruction (e.g., PCL, MCL, LCL Grade III).\n\nSignificant chondral damage (Outerbridge grade \\> 2 on pre-operative MRI or intra-operative assessment).\n\nPre-existing knee osteoarthritis (Kellgren-Lawrence grade \\> 2). Systemic inflammatory conditions (e.g., rheumatoid arthritis). Bleeding disorders or coagulopathies. Current use of anticoagulants. Corticosteroid injection into the knee within 6 weeks prior to surgery. Pregnancy or lactation. Inability to comply with the rehabilitation protocol. Infection or history of infection in the affected knee. History of previous contralateral ACL injury (to isolate primary injury outcomes).\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07470359', 'briefTitle': 'Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma Injection.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lahore General Hospital'}, 'officialTitle': 'Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma Injection: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LahoreGeneral1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraarticular PRP Group', 'description': 'Intraarticular Platelet rich plasma injection', 'interventionNames': ['Biological: PRP injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline group', 'description': 'Normal saline group', 'interventionNames': ['Biological: PRP injection']}], 'interventions': [{'name': 'PRP injection', 'type': 'BIOLOGICAL', 'description': 'Platelets rich plasma from patients own blood', 'armGroupLabels': ['Intraarticular PRP Group', 'Saline group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Lahore General Hospital', 'role': 'CONTACT', 'email': 'Lahoregeneralhospital@yahoo.com', 'phone': '+9242992688019'}], 'facility': 'Lahore General Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Hafiz Sohail Ahmad, Dr', 'role': 'CONTACT', 'email': 'Hafiz.sohail.315@gmail.com', 'phone': '+923204085069'}, {'name': 'Abdul Subhan Zahid, Dr', 'role': 'CONTACT', 'email': 'Abdulsubhanzahid3@gmail.com', 'phone': '+923104052587'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahore General Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Graduate Resident', 'investigatorFullName': 'Hafiz Sohail Ahmad', 'investigatorAffiliation': 'Lahore General Hospital'}}}}