Femoral FracturesNCT01553630
Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia
A study testing RIA bone graft and Surgery without bone graft in people with Femoral Fractures and Tibial Fractures, run by Florida Orthopaedic Institute at 2 sites in United States.
Trial summary
Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Femoral Fractures, Tibial Fractures
- What is being tested?
- RIA bone graft and Surgery without bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High energy metaphyseal fracture (distal femur or tibia) indicated for plate fixation (open or closed)
- Adult, acute fractures only
Who cannot join
- Unable to ream fractured bone
- Subject is unable, unwilling or unlikely to follow up
- Subject is under age 18 years
- Prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tampa General Hospital
Tampa, Florida, 33606
St Jospehs Hospital
Tampa, Florida, 33607
About this study
Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved.
Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures
Read the detailed description
Study procedures:
Eligible fractures will be identified, consented and randomized to RIA augmentation or non graft treatment. Bone graft will be harvested through the fracture at the time of the definitive fixation procedure. No additional graft can be utilized acutely (No iliac crest bone graft, or INFUSE, OP-1, Callos, etc).
Randomization Procedures: We will be using Research Randomizer to calculate a random assignment design for Group A and Group B, which will be kept by the Research Coordinator. Once a patient agrees to participate in the study and signs an Informed Consent Form, the treating surgeon will request the treatment assignment from the Research Coordinator prior to the surgery. Group A will receive RIA augmentation. Group B will receive non-graft treatment. Patient outcomes will be analyzed using intention to treat principles.
Surgical Procedures: Locked lateral plating of comminuted supracondylar femur and distal tibia fractures is an accepted standard of care. In severely comminuted fracture patterns, restoration of length and alignment often leaves substantial fracture gap increasing the risk of fracture nonunion. Historically, this has been accepted with the plan to return to the patient to surgery for bone grafting at a later date if the nonunion is developing. Intra-focal reaming with irrigation \& aspiration (RIA) at time of initial surgery allows for acute autogenous bone grafting with no increased morbidity to the patient.
Surgery for Group A receiving bone graft follows the same course as without acute grafting (same incision, dissection etc.) with the exception that after initial exposure, a guide wire is placed into the proximal femoral canal (retrograde) through the fracture, and graft is harvested using the RIA system. The RIA system has a reservoir to collect the reamings as they are aspirated from the fracture site. Reduction and fixation with locked plates then proceed as usual and the harvested graft is then placed into the residual gap with the expectation that nonunion rates may be decreased. A theoretical advantage is the renewed fracture hematoma that will collect at the fracture site secondary to reaming the canal which may also increase union rates and time to union. No increased morbidity is incurred and the increased surgical time is under 10 minutes.
- Conditions
- Femoral Fractures, Tibial Fractures
- Being tested
- RIA bone graft, Surgery without bone graft
- Keywords
- Fractures, distal femur fractures, distal tibial fracures
- Medical subject headings
- Femoral Fractures, Tibial Fractures, Fractures, Bone, Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIA bone graftProcedure or surgery
Acute autogenous bone grafting with RIA graft at the time of surgical fixation.
Surgery without bone graftProcedure or surgery
Plating of fracture without bone graft
| Study group | Role | What they receive |
|---|---|---|
| RIA bone graft | Active comparator | Surgery: open reduction and internal fixation (ORIF) of high energy metaphyseal fractures with Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation. Receives: Procedure: RIA bone graft |
| Surgery without bone graft | Active comparator | Surgery:open reduction and internal fixation (ORIF) of high energy metaphyseal fractures without Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation. Receives: Procedure: Surgery without bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to union
This will be evaluated with the reading of xrays
Measured: 3 months, 6 months and 1 year
Secondary outcomes (1)
Reoperation rate
The rate of re operation will be evaluated
Measured: 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553630
- Sponsor's protocol ID
- Reamed Locked Plating
- Status last verified
- Nov 2014
- First submitted
- 8 Mar 2012
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.
PubMed 36197809
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia
- ClinicalTrials.gov ID
- NCT01553630
- Acronym / sponsor ID
- Reamed Locked Plating
- Conditions
- Femoral Fractures, Tibial Fractures
- Keywords
- Fractures, distal femur fractures, distal tibial fracures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved.
Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures
Detailed description
Study procedures:
Eligible fractures will be identified, consented and randomized to RIA augmentation or non graft treatment. Bone graft will be harvested through the fracture at the time of the definitive fixation procedure. No additional graft can be utilized acutely (No iliac crest bone graft, or INFUSE, OP-1, Callos, etc).
Randomization Procedures: We will be using Research Randomizer to calculate a random assignment design for Group A and Group B, which will be kept by the Research Coordinator. Once a patient agrees to participate in the study and signs an Informed Consent Form, the treating surgeon will request the treatment assignment from the Research Coordinator prior to the surgery. Group A will receive RIA augmentation. Group B will receive non-graft treatment. Patient outcomes will be analyzed using intention to treat principles.
Surgical Procedures: Locked lateral plating of comminuted supracondylar femur and distal tibia fractures is an accepted standard of care. In severely comminuted fracture patterns, restoration of length and alignment often leaves substantial fracture gap increasing the risk of fracture nonunion. Historically, this has been accepted with the plan to return to the patient to surgery for bone grafting at a later date if the nonunion is developing. Intra-focal reaming with irrigation \& aspiration (RIA) at time of initial surgery allows for acute autogenous bone grafting with no increased morbidity to the patient.
Surgery for Group A receiving bone graft follows the same course as without acute grafting (same incision, dissection etc.) with the exception that after initial exposure, a guide wire is placed into the proximal femoral canal (retrograde) through the fracture, and graft is harvested using the RIA system. The RIA system has a reservoir to collect the reamings as they are aspirated from the fracture site. Reduction and fixation with locked plates then proceed as usual and the harvested graft is then placed into the residual gap with the expectation that nonunion rates may be decreased. A theoretical advantage is the renewed fracture hematoma that will collect at the fracture site secondary to reaming the canal which may also increase union rates and time to union. No increased morbidity is incurred and the increased surgical time is under 10 minutes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIA bone graft | Active comparator | Procedure: RIA bone graftSurgery: open reduction and internal fixation (ORIF) of high energy metaphyseal fractures with Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation. |
| Surgery without bone graft | Active comparator | Procedure: Surgery without bone graftSurgery:open reduction and internal fixation (ORIF) of high energy metaphyseal fractures without Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High energy metaphyseal fracture (distal femur or tibia) indicated for plate fixation (open or closed)
- Adult, acute fractures only
Key exclusion criteria (4 listed)
- Unable to ream fractured bone
- Subject is unable, unwilling or unlikely to follow up
- Subject is under age 18 years
- Prisoners
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 |
|---|---|---|
| RIA bone graftAcute autogenous bone grafting with RIA graft at the time of surgical fixation. | Procedure or surgery | RIA bone graft |
| Surgery without bone graftPlating of fracture without bone graft | Procedure or surgery | Surgery without bone graft |
Primary outcome
Time to union
Time frame: 3 months, 6 months and 1 year
This will be evaluated with the reading of xrays
1 secondary outcome
Reoperation rate
Time frame: 3 months, 6 months, 1 year
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
- Derived from this study: PubMed 36197809Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIA bone graft and Surgery without bone graft in people with Femoral Fractures and Tibial Fractures, run by Florida Orthopaedic Institute at 2 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
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?
Time to union (time frame: 3 months, 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01553630, which also lists 1 linked publication.
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 Nov 2014.