Proximal (Subtrochanteric)Femoral FracturesPhase 1/2NCT01687530
Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures
A Phase 1/2 study testing AMCA Bone Membrane. in people with Proximal (Subtrochanteric)Femoral Fractures and Distal Femoral Fractures, run by RegeneCure, Ltd. at 2 sites in Israel.
Trial summary
Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Proximal (Subtrochanteric)Femoral Fractures, Distal Femoral Fractures
- What is being tested?
- AMCA Bone Membrane.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years
- Both males and females
- Females of child-bearing potential who have a negative urine hCG pregnancy test following informed consent and prior to surgical procedure and who are not planning to become pregnant for the duration of their part in the study
- Femoral subtrochanteric fracture. The fracture is classified as one of the following:
- Closed fracture B. AO 31 A3, 33b + C1 + C2, and extending to the distal third
- Proximal subtrochanteric femoral fracture will be treated with a cephalomedullary nail.
- Patients must be available for follow-up for a minimum of 12 months.
Who cannot join
- Trauma presentation
- Open fractures
- Bilateral fractures
- Polytrauma with head injury
- Presence of periprosthetic fractures
- Patient Medical History
Show all 22Show fewer
- Previous malignancy (except basal cell carcinoma of the skin)
- Active autoimmune disease
- Metabolic bone disease (primary or secondary)
- Chronic renal insufficiency (defined by a Glomerular Filtration Rate of <30 ml/min)
- Liver function abnormality (defined by presence of ALT or AST levels more than double the upper limit)
- Current smoker
- Concurrent medication
- o Medications that may interfere with bone metabolism including:
- Calcitonin for 7 days or more within the last 6 months prior to study
- Bisphosphonates for 30 days or more within the last 12 months prior to study
- Bone therapeutic doses of vitamin D or vitamin D metabolites for 30 days or more within the last 6 months
- Previous or present immunosuppressive treatment
- Previous radiotherapy or chemotherapy
- Cumulative dose of 150mg total prednisolone or any other gluco-corticosteroid for 7 days or more within the last 6 months prior to study
- Previous history of or current alcohol abuse
- Previous history of or current drug addiction/abuse
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Organization, Orthopedic Surgery Department
Jerusalem
Amal Khoury, M.D, 972-2-6779549, akhoury@hadassah.org.il
Orthopedic Department, Hadassah Medical Organization
Jerusalem
Amal Khoury, +97226779549
About this study
Official title: Randomised Controlled Trial to Evaluate the Safety Performance and Initial Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Proximal (Subtrochanteric) Femoral Fractures
Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of bone and ectopic bone formation.
A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR has been widely used in the field of dentistry since the 1980s to provide stable placement for dental implants
The purpose of this study is to evaluate the safety, performance and initial efficacy of Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
- Being tested
- AMCA Bone Membrane.
- Medical subject headings
- Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMCA Bone Membrane.Procedure or surgery
AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
| Study group | Role | What they receive |
|---|---|---|
| AMCA bone membrane | Experimental | AMCA Bone is manufactured from Polyethylene Glycol 400 and Ammonio Methacrylate copolymer type A (Eudragit RL 100) materials. Receives: Procedure: AMCA Bone Membrane. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric femoral fractures.
Safety element will be measured by evaluation of swelling, clinical signs of superficial or deep infection, pain in the operated area.
Radiographic healing assessment score.
Measured: 12 months
Secondary outcomes (1)
To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union.
efficacy will be assessed by radiographic evaluation and functional assessment at different time points.
To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union, assessed by a difference of ten points in reduction of the completed Harris hip score at 16 weeks from baseline.
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 posted19 Sep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal (Subtrochanteric)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RegeneCure, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amal Khoury, M.D, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687530
- Sponsor's protocol ID
- REGO01/12
- Status last verified
- Aug 2013
- First submitted
- 9 Sep 2012
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Evaluate the Safety Performance and Initial Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Proximal (Subtrochanteric) Femoral Fractures
- ClinicalTrials.gov ID
- NCT01687530
- Acronym / sponsor ID
- REGO01/12
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- RegeneCure, Ltd.Industry (pharma, biotech, devices)
- First posted
- 19 Sep 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.
Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of bone and ectopic bone formation.
A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR has been widely used in the field of dentistry since the 1980s to provide stable placement for dental implants
The purpose of this study is to evaluate the safety, performance and initial efficacy of Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMCA bone membrane | Experimental | Procedure: AMCA Bone Membrane.AMCA Bone is manufactured from Polyethylene Glycol 400 and Ammonio Methacrylate copolymer type A (Eudragit RL 100) materials. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 to 65 years
- Both males and females
- Females of child-bearing potential who have a negative urine hCG pregnancy test following informed consent and prior to surgical procedure and who are not planning to become pregnant for the duration of their part in the study
- Femoral subtrochanteric fracture. The fracture is classified as one of the following:
- Proximal subtrochanteric femoral fracture will be treated with a cephalomedullary nail.
Key exclusion criteria (22 listed)
- Trauma presentation
- Patient Medical History
- Concurrent medication
- Calcitonin for 7 days or more within the last 6 months prior to study
- Bisphosphonates for 30 days or more within the last 12 months prior to study
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 |
|---|---|---|
| AMCA Bone Membrane.AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications. | Procedure or surgery | AMCA bone membrane |
Primary outcome
To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric femoral fractures.
Time frame: 12 months
Safety element will be measured by evaluation of swelling, clinical signs of superficial or deep infection, pain in the operated area. Radiographic healing assessment score.
1 secondary outcome
To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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.
Hadassah Medical Organization, Orthopedic Surgery Department
Jerusalem, Israel
Amal Khoury, M.D study director
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMCA Bone Membrane. in people with Proximal (Subtrochanteric)Femoral Fractures and Distal Femoral Fractures, run by RegeneCure, Ltd. at 2 sites in Israel.
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 7 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 27 Aug 2013. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric femoral fractures. (time frame: 12 months). 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 27 Aug 2013.