[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05073263":3,"trial-entities:NCT05073263":113,"trial-summary:NCT05073263":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":45,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":83,"locations":86,"central_contacts":103,"overall_officials":108,"references":111,"see_also_links":112},"NCT05073263","RFL_FWB vs PWB-FCL","Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction","Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: a Randomized Controlled Trial","RECRUITING","2026-01","2024-11","2024-11-22","2020-01-01","Twin Cities Orthopedics","OTHER",false,"This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.","Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:\n\n1. partial weightbearing\n2. full controlled weightbearing\n\nAn immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing.\n\nSpecific Aims\n\n1. Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee.\n2. Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups.\n\nThe Investigators hypothesize that there will be no clinically significant difference (\\\u003C 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis.\n\nThe current standard of care for FCL reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.",[19],"Knee Injuries",[21,22],"fibular collateral ligament (FCL)","anterior cruciate ligament (ACL)","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},50,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Physical Therapy","Patient is randomized to the weightbearing group the day after surgery.",[35,36],"Full weight -bearing for the first six weeks after surgery","Partial weight -bearing for the first six weeks after surgery",[38,42],{"measure":39,"description":40,"timeFrame":41},"Gapping (mm) measured on Standard of Care Varus stress radiographs","stress radiograph","Pre-operative",{"measure":43,"description":40,"timeFrame":44},"Gapping (mm) measured Standard of Care Varus stress radiographs","6 months post-surgery",[46,50,54,57,60],{"measure":47,"description":48,"timeFrame":49},"Numeric Pain Scale (NPS) (0-10 rating)","Pain scale 0-100","Baseline and 6 months",{"measure":51,"description":52,"timeFrame":53},"Measurements by physical therapists (Edema, thigh circumference)","Measurements with tape","4,7, and 10 months after surgery",{"measure":55,"description":56,"timeFrame":53},"Measurements by physical therapists (Range of Motion)","Measurements with goniometer",{"measure":58,"description":59,"timeFrame":53},"Measurements by physical therapists (Quadriceps strength, gait analysis)","Measurements by biomechanics lab",{"measure":61,"description":62,"timeFrame":63},"Patient reported outcome scores","Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey\u002Fpatient satisfaction","Baseline, 3 months, 6 months, 1 year","ALL","14 Years","59 Years",true,{"inclusion":69,"exclusion":75,"raw_text":82},[70,71,72,73,74],"≥ 14 years old, \\\u003C60","Reconstruction of FCL alone","Combined FCL + ACL reconstructions","Males or females","Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.",[76,77,78,79,80,81],"\\\u003C 14 years old, \\> 60","Pregnant","Revision FCL reconstructions","Concurrent biceps femoris or lateral capsular repairs","Concurrent PCL or MCL reconstructions","Concomitant meniscus root or radial repair surgery with transtibial technique","Inclusion Criteria:\n\n* ≥ 14 years old, \\\u003C60\n* Reconstruction of FCL alone\n* Combined FCL + ACL reconstructions\n* Males or females\n* Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.\n\nExclusion Criteria:\n\n* \\\u003C 14 years old, \\> 60\n* Pregnant\n* Revision FCL reconstructions\n* Concurrent biceps femoris or lateral capsular repairs\n* Concurrent PCL or MCL reconstructions\n* Concomitant meniscus root or radial repair surgery with transtibial technique",[84,85],"CHILD","ADULT",[87],{"facility":13,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":100},"Edina","Minnesota","55435","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Becky Stone","CONTACT","952-456-7136","research@tcomn.com",{"name":99,"role":95},"Robert F LaPrade, MD, PhD",{"lat":101,"lon":102},44.88969,-93.34995,[104,105],{"name":94,"role":95,"phone":96,"email":97},{"name":106,"role":95,"phone":107,"email":97},"Kayla Seiffert","952-456-7085",[109],{"name":99,"affiliation":13,"role":110},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":118},[115,116,117],"Fibular Collateral Ligament Injury","Injury of anterior cruciate ligament","Knee Injury",[],{"nct_id":4,"found":67,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study that will randomly assign 50 participants to one of two rehabilitation groups. It is not specified if participants or researchers will know which group you are in.","completed","Rehab After Fibular Collateral Ligament Reconstruction","This study is looking at whether patients who have surgery to fix their fibular collateral ligament (FCL) – a knee ligament – can safely put full weight on their leg sooner after surgery. You would be randomly assigned to either put partial weight or full weight on your leg for the first six weeks after surgery. Researchers will measure the gapping (how much the knee opens up) in your knee at six months after surgery to see if there's a difference between the two groups. They also want to see how this affects pain, swelling, movement, and strength. This study is for people aged 14 to 59 who are having FCL reconstruction, possibly with an ACL (anterior cruciate ligament) reconstruction. The study is currently unclear on its recruitment status.","Your knee gapping will be measured at six months after surgery.",129,"You would be randomized to a weightbearing group the day after surgery. You would use a knee brace for the first six weeks after surgery.","Not stated in the trial record.",[],"v2"]