Single Versus Dual Implant Fixation of Distal Femur Fractures
Not Applicable
Not yet recruiting
- Conditions
- Articular Fractures
- Registration Number
- NCT06286670
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
Inclusion Criteria:<br><br> - Age greater than or equal to 18 years<br><br> - Surgically treated displaced distal femur extra articular or complete articular<br> fractures<br><br>Exclusion Criteria:<br><br> - Patients with injury features that preclude treatment with 2 implants<br><br> - Patients unlikely to follow-up due to homelessness, or planning follow up at another<br> institution<br><br> - Body Mass Index (BMI) > 40<br><br> - Injury due to ground level fall<br><br> - Patient that speaks neither English or Spanish<br><br> - Patients with multisystem injuries that could preclude return to work<br><br> - < 18 years of age<br><br> - Prisoner
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Return to Work - International Physical Activity Questionnaire (IPAQ) Scores;Return to Work - International Physical Activity Questionnaire (IPAQ) Scores;Return to Work - International Physical Activity Questionnaire (IPAQ) Scores;Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
- Secondary Outcome Measures
Name Time Method Number of Unions;Number of Resource Utilizations;Number of Reoperations;Number of Complications;Time to Walking Without an Assistive Device;Prescribed Weight Bearing Status;Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores;Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores;Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores;Change in the Work Productivity and Activity Impairment Questionnaire Scores;Change in Numeric Pain Rating;Change in Pain Inventory (BPI);Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference;Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification;Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS;Isokinetic Knee Flexion/Extension Strength Testing;Counter-Movement Jump measurement;Single Leg Static and Dynamic Postural Stability Index;Triple Hop Performance Assessment