Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT02300012
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2014-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat.', 'timeFrame': 'Baseline, 6 weeks'}, {'measure': 'The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'The change in peak vertical ground reaction force from baseline to 6 weeks post-ACL reconstruction, measured when performing a novel isometric task during sitting.', 'timeFrame': 'Baseline, 6 weeks'}, {'measure': 'The change in peak vertical ground reaction force from baseline to 6 months post-ACL reconstruction, measured when performing a novel isometric task during sitting.', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'The change in anterior-posterior centre of pressure displacement from baseline to 6 weeks post-ACL reconstruction, measured when performing a 10 second standing balance task.', 'timeFrame': 'Baseline, 6 weeks'}, {'measure': 'The change in anterior-posterior centre of pressure displacement from baseline to 6 months post-ACL reconstruction, measured when performing a 10 second standing balance task.', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'The change in time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction', 'timeFrame': 'Baseline, 6 weeks'}, {'measure': 'The change in time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction', 'timeFrame': 'Baseline, 6 months'}], 'secondaryOutcomes': [{'measure': 'The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction', 'timeFrame': '6 months post-ACL reconstruction'}, {'measure': 'The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction', 'timeFrame': '6 months post-ACL reconstruction'}, {'measure': 'The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction', 'timeFrame': '6 months post-ACL reconstruction'}, {'measure': 'The change in International Knee Documentation Committee subjective knee evaluation form from baseline to 6 months post-ACL reconstruction', 'timeFrame': 'baseline to 6 months post-ACL reconstruction'}, {'measure': 'The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction', 'timeFrame': 'At time of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament', 'Performance based investigations'], 'conditions': ['Rupture of Anterior Cruciate Ligament']}, 'descriptionModule': {'briefSummary': 'Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.\n\nPerformance Based Investigations (PBIs) can be used to evaluate and select correct approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers in other conditions are sensitive in distinguishing between disease state severities, type of injuries and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not widely used possibly owing to their focus postoperatively where benefits are less worthwhile.\n\nThis study aims to investigate novel biomarkers as performance based investigations (PBIs) to improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The objectives are to identify whether biomarkers, collected before and after operations, can: 1) Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further understand ACL injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral ACL rupture\n* 18 - 45 years old\n\nExclusion Criteria:\n\n* combined posterior and ACL rupture\n* multi-ligament instability including medial or lateral collateral ligament injury\n* other lower limb surgery \\<3mths\n* current significant acute injury affecting other lower extremity joints, or other relevant neurological or musculoskeletal pathology.'}, 'identificationModule': {'nctId': 'NCT02300012', 'briefTitle': 'A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'United Lincolnshire Hospitals NHS Trust'}, 'officialTitle': 'A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls', 'orgStudyIdInfo': {'id': '120614Mullineaux'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Operation - No PBI', 'description': 'Patients requiring operation - baseline PBI data not seen by surgeon'}, {'type': 'EXPERIMENTAL', 'label': 'Operation - PBI available', 'description': 'Patients requiring operation - baseline PBI data seen by surgeon pre-operatively', 'interventionNames': ['Procedure: Surgeons knowledge of pre-operative PBIs']}, {'type': 'NO_INTERVENTION', 'label': 'Non-operation', 'description': 'Patients with ACL rupture not requiring operation'}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Healthy age matched volunteers - No operation'}], 'interventions': [{'name': 'Surgeons knowledge of pre-operative PBIs', 'type': 'PROCEDURE', 'description': 'Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice', 'armGroupLabels': ['Operation - PBI available']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LN2 5QY', 'city': 'Lincoln', 'state': 'Lincolnshire', 'country': 'United Kingdom', 'facility': 'United Lincolnshire Hospitals NHS Trust', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}], 'overallOfficials': [{'name': 'Prof David Mullineaux, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lincoln'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Lincolnshire Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lincoln', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}