Femoral FracturesNCT00429663
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
A study testing reamed, interlocking intramedullary nail and locking periarticular plate in people with Femoral Fractures, run by Boston Medical Center at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- reamed, interlocking intramedullary nail and locking periarticular plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 22 sitesUnited States
- Study dates
- Feb 2007to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
University of Maryland Medical Center
Baltimore, Maryland, 21201
Boston Medical Center
Boston, Massachusetts, 02118
Cooper University Hospital
Camden, New Jersey, 08103
Ohio State University Medical Center
Columbus, Ohio, 43210
Orthopaedic Specialty Associates Fort Worth
Fort Worth, Texas, 76104
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
Indiana University
Indianapolis, Indiana, 46202
Campbell Foundation
Memphis, Tennessee, 38104
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
New York Hospital for Joint Diseases
New York, New York, 10003
University of Oklahoma/ Health Science
Oklahoma City, Oklahoma, 73190
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health and Sciences University
Portland, Oregon, 97239
St. Mary's Hospital - Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester Medical Center
Rochester, New York, 14642
University of California - Davis
Sacramento, California, 95817
Harborview Medical Center
Seattle, Washington, 98104
Barnes Hospital
St Louis, Missouri, 63110
St. Louis University Hospital
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
UMass Memorial Medical Center
Worchester, Massachusetts, 01605
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Femoral Fractures
- Being tested
- reamed, interlocking intramedullary nail, locking periarticular plate
- Keywords
- distal femur, femur fracture
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reamed, interlocking intramedullary nailDevice
Standard of care device for femur fracture repair
locking periarticular plateDevice
Standard of care device for femur fractures
| Study group | Role | What they receive |
|---|---|---|
| IM Nails | Other | Reamed, Interlocking Intramedullary Nail - Randomized treatment Receives: Device: reamed, interlocking intramedullary nail |
| Plate Fixation | Other | Locking Periarticular Plate - Randomized Treatment Receives: Device: locking periarticular plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D
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.
Measured: 3 months, 6 months, 12 months
Short Musculoskeletal Functional Assessment (SMFA) Score
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.
Measured: 3 months, 6 months, 12 months
EQ Index
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.
Measured: 3 months, 6 months, 12 months
SMFA - Bother Index
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.
Measured: 3 months, 6 months, 12 months
Secondary outcomes (1)
Valgus of Over 5 Degrees
Valgus is a deformity involving oblique displacement of part of a limb away from the midline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Tornetta, III, M.D., Boston Medical Center
- Investigators
- Paul Tornetta, M.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429663
- Sponsor's protocol ID
- H-25934
- Status last verified
- Apr 2017
- First submitted
- 30 Jan 2007
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00429663
- Acronym / sponsor ID
- H-25934
- Conditions
- Femoral Fractures
- Keywords
- distal femur, femur fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Posted 9 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IM Nails | Other | Device: reamed, interlocking intramedullary nailReamed, Interlocking Intramedullary Nail - Randomized treatment |
| Plate Fixation | Other | Device: locking periarticular plateLocking Periarticular Plate - Randomized Treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reamed, interlocking intramedullary nailStandard of care device for femur fracture repair | Device | IM Nails |
| locking periarticular plateStandard of care device for femur fractures | Device | Plate Fixation |
Primary outcome
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.
1 secondary outcome
Valgus of Over 5 Degrees
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Tornetta, M.D. principal investigator
Boston University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reamed, interlocking intramedullary nail and locking periarticular plate in people with Femoral Fractures, run by Boston Medical Center at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D (time frame: 3 months, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.