N/A
N=99
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
Tibial Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00429585 ↗Enrolled (actual)
99
Serious AEs
6.1%
Results posted
Nov 2021
Primary outcome: Primary: Participants' Quality of Life at 3 Months — 0.60; 0.59 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- reamed, interlocking intramedullary nail (Device); locking periarticular plate (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants' Quality of Life at 3 Months |
0.60; 0.59 | — |
| PRIMARY Participants' Quality of Life at 6 Months |
0.65; 0.72 | — |
| PRIMARY Participants' Quality of Life at 12 Months |
0.60; 0.775 | — |
| PRIMARY Injury Related Limitations and Concerns at 3 Months |
40.25; 40.11 | — |
| PRIMARY Injury Related Limitations and Concerns at 6 Months |
32.19; 27.70 | — |
| PRIMARY Injury Related Limitations and Concerns at 12 Months |
34.20; 23.51 | — |
| SECONDARY Number of Participants With Fracture Nonunions |
4; 5 | — |
| SECONDARY Number of Participants With Superficial Infections |
0; 2 | — |
| SECONDARY Number of Participants With Deep Infections |
3; 1 | — |
| SECONDARY Number of Participants With Compartment Syndrome |
1; 0 | — |
| SECONDARY Number of Participants With Malunion (>5 Degrees Varus/Valgus) |
3; 3 | — |
Summary
This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia 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,
- Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete anteroposterior (AP) and lateral radiographs,
- Major fracture line not closer than 4cm from the proximal tibial articular surface
- Fracture requiring operative treatment amenable to either IM nail or plate
- Surgeon agreed to randomize patient
- Informed consent obtained
- Patient is English speaking
Exclusion Criteria
- Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface),
- Fracture of the proximal tibia with intraarticular extension requiring open reduction,
- Known metabolic bone disease
- Separate displaced tibial tubercle fragment,
- Soft tissue injuries compromising treatment method with nail,plate or both.
- Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair,
- Compartment syndrome of the leg diagnosed preoperatively,
- Pathological fractures,
- Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both,
- Symptomatic knee arthritis.
- 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 (NCT00429585). 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.