N/A
N=156
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
Femoral Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00429663 ↗Enrolled (actual)
156
Serious AEs
4.5%
Results posted
Feb 2017
Primary outcome: Primary: EQ-5D — 69.23; 72.81; 74.24; 73.04 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- reamed, interlocking intramedullary nail (Device); locking periarticular plate (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EQ-5D |
69.23; 72.81; 74.24; 73.04; 79.07; 71.9 | — |
| PRIMARY Short Musculoskeletal Functional Assessment (SMFA) Score |
38.76; 41.58; 29.82; 31.92; 22.18; 26.83 | — |
| PRIMARY EQ Index |
0.63; 0.59; 0.73; 0.68; 0.76; 0.70 | — |
| PRIMARY SMFA - Bother Index |
40.46; 36.75; 28.23; 29.94; 22.97; 28.93 | — |
| SECONDARY Valgus of Over 5 Degrees |
10; 20 | — |
Summary
This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.
Eligibility Criteria
Inclusion Criteria
- Skeletally mature
- Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA
- Fracture requiring operative treatment amenable to either IM nail or plate
- Informed consent obtained
- Patient is English speaking
Exclusion Criteria
- Fracture of the metaphyseal distal femur with intra-articular communition,
- Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair,
- Pathological fracture,
- Known metabolic bone disease,
- Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
- Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
- Symptomatic knee arthritis
- Soft tissue injuries compromising either treatment method with nail or plate
- Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures
- Immunocompromised
- Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
- Current or impending incarceration
- Unlikely to follow-up in surgeon's estimation
Data sourced from ClinicalTrials.gov (NCT00429663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.