A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00429663 |
|
Recruitment Status :
Completed
First Posted : February 1, 2007
Results First Posted : February 9, 2017
Last Update Posted : May 11, 2017
|
Sponsor:
Boston Medical Center
Information provided by (Responsible Party):
Paul Tornetta, III, M.D., Boston Medical Center
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Femoral Fractures | Device: reamed, interlocking intramedullary nail Device: locking periarticular plate | Not Applicable |
The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (S.O.L.V.E.D) |
| Study Start Date : | February 2007 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2016 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
IM Nails
Reamed, Interlocking Intramedullary Nail - Randomized treatment
|
Device: reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair |
|
Plate Fixation
Locking Periarticular Plate - Randomized Treatment
|
Device: locking periarticular plate
Standard of care device for femur fractures |
Primary Outcome Measures :
- EQ-5D [ Time Frame: 3 months, 6 months, 12 months ]EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.
- Short Musculoskeletal Functional Assessment (SMFA) Score [ Time Frame: 3 months, 6 months, 12 months ]The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.
- EQ Index [ Time Frame: 3 months, 6 months, 12 months ]EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.
- SMFA - Bother Index [ Time Frame: 3 months, 6 months, 12 months ]The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.
Secondary Outcome Measures :
- Valgus of Over 5 Degrees [ Time Frame: 12 months ]Valgus is a deformity involving oblique displacement of part of a limb away from the midline.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429663
Locations
Show 22 study locations
Sponsors and Collaborators
Boston Medical Center
Investigators
| Principal Investigator: | Paul Tornetta, M.D. | Boston University |
| Responsible Party: | Paul Tornetta, III, M.D., Paul Tornetta,III,M.D, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00429663 |
| Other Study ID Numbers: |
H-25934 |
| First Posted: | February 1, 2007 Key Record Dates |
| Results First Posted: | February 9, 2017 |
| Last Update Posted: | May 11, 2017 |
| Last Verified: | April 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Paul Tornetta, III, M.D., Boston Medical Center:
|
distal femur femur fracture |
Additional relevant MeSH terms:
|
Fractures, Bone Femoral Fractures Wounds and Injuries Leg Injuries |