Geriatric Distal Femur
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single Implant Fixation, Dual Implant Fixation.
- Who it may be relevant to
- Registry conditions: Articular Fractures. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Single Impact Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures in Geriatric Patients
Overview
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.
Detailed description
Fractures of the distal femur are severe and common injuries sustained by older adults. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to activities of daily living and impacts quality of life. Despite numerous studies of a variety of different surgical treatment strategies, the incidence of nonunion remains high. Therefore, any novel strategy to reduce the risk of nonunion and accelerate return to activities after distal femur fracture warrants rigorous study. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.
Interventions
- Procedure Single Implant Fixation
Lateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement. - Procedure Dual Implant Fixation
Lateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater.
Primary outcome measures
- Number of Unions [Time frame: 6-week, 3, 6, 12 months]
- Total Surgical Time - Reoperations [Time frame: 6-week, 3, 6, 12 months]
- Number of Reoperations [Time frame: 6-week, 3, 6, 12 months]
Secondary outcome measures (12)
- Number of Resource Utilizations [Time frame: 6-week, 3, 6, 12 month]
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Week 6]
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Month 3]
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Month 6]
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Month 12]
- Time to Walking Without an Assistive Device [Time frame: 6-week, 3, 6, 12 months]
- Prescribed Weight Bearing Status [Time frame: 6-week, 3, 6, 12 months]
- Fear of Movement -Tampa Scale for Kinesiophobia (TSK) Scores [Time frame: 6-week, 3, 6, 12 months]
- Health Related Quality of Life - Patient-Reported Outcomes Measurement Information System (PROMIS) Scores [Time frame: 6-week, 3, 6, 12 months]
- Global Health Status - Veterans RAND 12 Item Health Survey (VR12) Scores [Time frame: 6-week, 3, 6, 12 months]
- Work Productivity and Activity Impairment Questionnaire Scores [Time frame: 6-week, 3, 6, 12 months]
- Numeric Pain Rating [Time frame: 6-week, 3, 6, 12 months]
Eligibility criteria
Inclusion criteria
- Age greater than or equal to 55 years
- Surgically treated displaced distal femur extra articular or complete articular fractures
Exclusion criteria
- Patients with injury features that preclude treatment with 2 implants
- Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
- Body Mass Index (BMI) > 40
- Injury due to ground level fall
- Patient that speaks neither English or Spanish
- Patients with multisystem injuries that could preclude return to work
- < 55 years of age
- Prisoner
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07237191 · IRB00139405