protocolSection identificationModule nctId: NCT06286670, orgStudyIdInfo id: IRB00108312, secondaryIdInfos id: HT94252311075, type: OTHER, domain: Department of Defense, briefTitle: Single Versus Dual Implant Fixation of Distal Femur Fractures, acronym: PRORP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities., conditionsModule conditions: Articular Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Single Implant Fixation, interventions name: Dual Implant Fixation, outcomesModule primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, secondaryOutcomes measure: Number of Unions, secondaryOutcomes measure: Number of Resource Utilizations, secondaryOutcomes measure: Number of Reoperations, secondaryOutcomes measure: Number of Complications, secondaryOutcomes measure: Time to Walking Without an Assistive Device, secondaryOutcomes measure: Prescribed Weight Bearing Status, secondaryOutcomes measure: Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores, secondaryOutcomes measure: Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores, secondaryOutcomes measure: Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores, secondaryOutcomes measure: Change in the Work Productivity and Activity Impairment Questionnaire Scores, secondaryOutcomes measure: Change in Numeric Pain Rating, secondaryOutcomes measure: Change in Pain Inventory (BPI), secondaryOutcomes measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference, secondaryOutcomes measure: Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification, secondaryOutcomes measure: Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS, secondaryOutcomes measure: Isokinetic Knee Flexion/Extension Strength Testing, secondaryOutcomes measure: Counter-Movement Jump measurement, secondaryOutcomes measure: Single Leg Static and Dynamic Postural Stability Index, secondaryOutcomes measure: Triple Hop Performance Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atrium Health Musculoskeletal Institute, city: Charlotte, state: North Carolina, zip: 28204, country: United States, contacts name: Erica Grochowski, role: CONTACT, email: Erica.Grochowski@atriumhealth.org, contacts name: Laurence Kempton, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22709, lon: -80.84313, hasResults: False