Tibial FracturesIMOCANCT00512434
Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
A study testing Osteosynthesis in people with Tibial Fractures and Fractures, Open, run by University Hospital, Tours at 11 sites in France.
Trial summary
The treatment of open tibial shaft fracture is often complicated by delayed union or non-union. The objective of this study is to evaluate the efficacy of autologous concentrated bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Tibial Fractures, Fractures, Open
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 11 sitesFrance
- Study dates
- Sep 2007to Sep 2013
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 17 years or more
- Open tibial shaft fracture with Gustilo-Anderson type I, II, III A or B
- Written informed consent
- Affiliated to French Social Security
Who cannot join
- Circumferential bone loss
- Vascular or nerve injury
- Injury, other than tibial fracture, interfering with weight bearing
- Infection (skin, soft-tissue or bone)
- Disease or treatment interfering with bone union: head injury with coma, pathologic fracture
- Medical history on iliac wing contraindicating bone-marrow aspiration
Show all 11Show fewer
- Corticoid or immunosuppressive therapy more than one week
- Pregnancy at the day of inclusion in study
- History of positive serology for HIV1+2, HBs, HCV
- Adult in the care of a guardian
- Impossibility to meet at the appointments for the follow-up
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
UH Angers
Angers, 49933
UH Besançon Jean Minjoz
Besançon, 25030
UH Brest Cavale Blanche
Brest, 29200
UH Clermont Ferrand Gabriel Montpied
Clermont-Ferrand, 63 000
UH Grenoble Michallon Hospital
Grenoble, 38043
UH Grenoble South Hospital
Grenoble, 38434
UH Nancy Central Hospital
Nancy, 54000
UH Nantes Hôtel Dieu
Nantes, 44
UH Pitié Salpétrière AH HP
Paris, 75013
UH Tours CHRU Trousseau
Tours, 37 044
UHTOURS
Tours
About this study
Official title: Injection of Concentrated Autologous Bone-marrow (IMOCA) and Bone Union of Open Tibial Shaft Fracture: Randomized Study to Assess Efficiency of IMOCA in Addition to Standard of Care.
The treatment of open tibial shaft fracture is often complicated by delayed union or non-union. The objective of this study is to evaluate the efficacy of autologous concentrated bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention.
In a prospective, randomized, controlled, single-blind study, 186 patients with an open tibial will be randomized to receive either the standard of care (fixation by nail or external fixator and routine soft-tissue management), or the standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow. Randomization will be stratified by severity of the open wound. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post-fracture.
Read the detailed description
This study will be conducted at 13 University Hospitals in France. The protocol has been approved by the institutional review board. After written informed consent, patients will be randomized, in the days after the fracture in 2 groups of 93 patients : 1) the control group (standard of care only: fixation by nail or external fixator and routine soft-tissue management) and 2) the study group (standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow). Randomization will be stratified by severity of the open wound and by center. For the wound, strata A comprise Gustilo-Anderson types I, II and III-A and strata B, type III-B.
For the study group, the injection is scheduled at 1 month ± 5 days after the fracture. The techniques have been described by Hernigou (J Bone Joint Surg Am, 2006; 88(sup 1 part 2): 322-327). There are 3 steps: marrow aspiration (300 - 500 g) from iliac crest under general anesthesia, centrifugation in cell therapy unit to obtain a concentrated buffy coat of about 50 ml containing progenitor cells and other mononuclear cells, percutaneous injection in the fracture site of 20-30 ml of the buffy coat under fluoroscopy control.
Apart from the injection, the standard of care is the same for the 2 groups. Patients will be followed for 12 months, with assessments at 1, 2, 3, 6, 9 and 12 months.
All analysis will be based on the intent to treat the population. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post fracture. An independent panel of surgeons will evaluate all secondary procedure with the potential of promoting fracture-healing.
An independent evaluation of fracture union will be conducted by a radiology panel blinded to treatment allocation and all other patient data.
An outcome will be considered to be successful when the fracture heal, according to the investigator, without secondary intervention and is radiographically united during patient follow-up.
- Conditions
- Tibial Fractures, Fractures, Open
- Being tested
- Osteosynthesis
- Keywords
- tibial, shaft, fracture, open, bone-marrow, graft, injection, mesenchymal stem cell
- Medical subject headings
- Tibial Fractures, Fractures, Open, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Nail or external fixator Intervention 'Osteosynthesis'
| Study group | Role | What they receive |
|---|---|---|
| Control in arm fields | Active comparator | Standard treatment Intervention no'Osteosynthesis' Receives: Procedure: Osteosynthesis |
| IMOCA | Experimental | Intervention 'Osteosynthesis' Percutaneous autologous bone-marrow grafting - surgical technique (ref: Hernigou Ph et al J Bone Joint Surg Am ,2006; 88 (sup 1 part 2): 322-327 Receives: Procedure: Osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture.
Measured: one year
Secondary outcomes (3)
Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union.
Measured: one year
Comparison of the rate of complications between the 2 groups.
Measured: one year
Economic impact study.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Rosset, Pr, Principal investigator, Service d'orthopédie II - CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512434
- Sponsor's protocol ID
- PHRN/06/PR/IMOCA
- Other IDs
- ID RCB 2007 - A00032 - 51
- Acronym
- IMOCA
- Status last verified
- Oct 2018
- First submitted
- 6 Aug 2007
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of Concentrated Autologous Bone-marrow (IMOCA) and Bone Union of Open Tibial Shaft Fracture: Randomized Study to Assess Efficiency of IMOCA in Addition to Standard of Care.
- ClinicalTrials.gov ID
- NCT00512434
- Acronym / sponsor ID
- IMOCA / PHRN/06/PR/IMOCA
- Conditions
- Tibial Fractures, Fractures, Open
- Keywords
- tibial, shaft, fracture, open, bone-marrow, graft, injection, mesenchymal stem cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Aug 2007 (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.
The treatment of open tibial shaft fracture is often complicated by delayed union or non-union. The objective of this study is to evaluate the efficacy of autologous concentrated bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention.
In a prospective, randomized, controlled, single-blind study, 186 patients with an open tibial will be randomized to receive either the standard of care (fixation by nail or external fixator and routine soft-tissue management), or the standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow. Randomization will be stratified by severity of the open wound. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post-fracture.
Detailed description
This study will be conducted at 13 University Hospitals in France. The protocol has been approved by the institutional review board. After written informed consent, patients will be randomized, in the days after the fracture in 2 groups of 93 patients : 1) the control group (standard of care only: fixation by nail or external fixator and routine soft-tissue management) and 2) the study group (standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow). Randomization will be stratified by severity of the open wound and by center. For the wound, strata A comprise Gustilo-Anderson types I, II and III-A and strata B, type III-B.
For the study group, the injection is scheduled at 1 month ± 5 days after the fracture. The techniques have been described by Hernigou (J Bone Joint Surg Am, 2006; 88(sup 1 part 2): 322-327). There are 3 steps: marrow aspiration (300 - 500 g) from iliac crest under general anesthesia, centrifugation in cell therapy unit to obtain a concentrated buffy coat of about 50 ml containing progenitor cells and other mononuclear cells, percutaneous injection in the fracture site of 20-30 ml of the buffy coat under fluoroscopy control.
Apart from the injection, the standard of care is the same for the 2 groups. Patients will be followed for 12 months, with assessments at 1, 2, 3, 6, 9 and 12 months.
All analysis will be based on the intent to treat the population. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post fracture. An independent panel of surgeons will evaluate all secondary procedure with the potential of promoting fracture-healing.
An independent evaluation of fracture union will be conducted by a radiology panel blinded to treatment allocation and all other patient data.
An outcome will be considered to be successful when the fracture heal, according to the investigator, without secondary intervention and is radiographically united during patient follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control in arm fields | Active comparator | Procedure: OsteosynthesisStandard treatment Intervention no'Osteosynthesis' |
| IMOCA | Experimental | Procedure: OsteosynthesisIntervention 'Osteosynthesis' Percutaneous autologous bone-marrow grafting - surgical technique (ref: Hernigou Ph et al J Bone Joint Surg Am ,2006; 88 (sup 1 part 2): 322-327 |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 17 years or more
- Open tibial shaft fracture with Gustilo-Anderson type I, II, III A or B
- Written informed consent
- Affiliated to French Social Security
Key exclusion criteria (11 listed)
- Circumferential bone loss
- Vascular or nerve injury
- Injury, other than tibial fracture, interfering with weight bearing
- Infection (skin, soft-tissue or bone)
- Disease or treatment interfering with bone union: head injury with coma, pathologic fracture
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 |
|---|---|---|
| OsteosynthesisNail or external fixator Intervention 'Osteosynthesis' | Procedure or surgery | Control in arm fields, IMOCA |
Primary outcome
Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture.
Time frame: one year
3 secondary outcomes
Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union.
Time frame: one year
Comparison of the rate of complications between the 2 groups.
Time frame: one year
Economic impact study.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
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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.
Philippe Rosset, Pr principal investigator
Service d'orthopédie II - CHRU de Tours
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteosynthesis in people with Tibial Fractures and Fractures, Open, run by University Hospital, Tours at 11 sites in France.
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 4 inclusion and 11 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 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture. (time frame: one year). 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 22 Oct 2018.