Hip FractureNCT00521716
Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation
A study testing Intracapsular Femoral Fracture Fixation and WaisFix100i for Intracapsular Femoral Fracture Fixation in people with Hip Fracture, run by OrthoMediTec at 1 site in Israel.
Trial summary
The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Intracapsular Femoral Fracture Fixation and WaisFix100i for Intracapsular Femoral Fracture Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Dec 2009
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female with Intracapsular femoral fracture type Garden I-II and several III.
- Age 50 to 75.
- Subject able to comprehend and give informed consent for participation in this study.
Who cannot join
- Known active infectious disease.
- Terminal diseases
- Patients in high risk and/or acute cardio-vascular disease.
- Known cognitive disorder, psychiatric and/or neurological disease
- Physician objection.
- Age under 50 or above 75.
- Concurrent participation in any other clinical study
- Patients cannot understand or not willing to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Uni-Center, Prospective Clinical Investigation to Evaluate Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation
The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.
Read the detailed description
Fractures of the neck of the femur represent an estimated cost to society that exceeds ten billion dollars annually in the USA only.
Fractures have been treated with immobilization, traction, amputation, and internal fixation throughout history. Immobilization by casting, bracing, or splinting a joint above and below the fracture was used for most long bone fractures.
Several studies have suggested that reduction and fixation of an Intracapsular fracture of the hip with multiple pins or screws is associated with a lower rate of morbidity and mortality than treatment with prosthetic replacement. With improved methods of fixation and a tendency toward earlier weight-bearing, internal fixation is believed to be a better mode of treatment for younger, more active patients.
On the other hand, the internal fixation procedure may result with number of possibilities for serious complications and biomechanical disadvantages, leading to the device failure. This led to a growing tendency to prefer total or partial hip replacement as the common treatment for intracapsular fracture, although the internal fixation is the favorable procedure in the professional literature.
OrthoMediTec has developed the WaisFix100i device, a new concept for Intracapsular Femoral Fracture Fixation and bone grafting using minimally invasive procedures. The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
The Internal Triangular Cage is inserted into the femoral neck as a strong, solid beam structure to guide and hold the screws in place. The cage supplies the structure to hold the bone graft and screws at the fracture site.
The objectives of this single arm, multi-center, prospective study, are to evaluate the safety and efficacy of using the WaisFix100i device in intracapsular femoral fracture fixation surgery.
- Conditions
- Hip Fracture
- Being tested
- Intracapsular Femoral Fracture Fixation, WaisFix100i for Intracapsular Femoral Fracture Fixation
- Keywords
- Hip Prosthesis Implantation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracapsular Femoral Fracture FixationDevice
Also called WaisFix100i
The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
WaisFix100i for Intracapsular Femoral Fracture FixationDevice
The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Intracapsular Femoral Fracture Fixation; Device: WaisFix100i for Intracapsular Femoral Fracture Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety endpoint is measure by paucity incidence of treatment related major complications.
Measured: Study duration
Secondary outcomes (1)
Efficacy endpoint is measure by the following: 1. A subject is scored a success if he had no revision surgery, hemi- arthroplasty or total hip replacement surgery by 12 months; 2. Time to functional recovery
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoMediTec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marc Waisman, Dr., Principal investigator, Carmel medical Center, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521716
- Sponsor's protocol ID
- WF-01
- Status last verified
- Feb 2008
- First submitted
- 26 Aug 2007
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Uni-Center, Prospective Clinical Investigation to Evaluate Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation
- ClinicalTrials.gov ID
- NCT00521716
- Acronym / sponsor ID
- WF-01
- Conditions
- Hip Fracture
- Keywords
- Hip Prosthesis Implantation
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- OrthoMediTecIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 28 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 purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.
Detailed description
Fractures of the neck of the femur represent an estimated cost to society that exceeds ten billion dollars annually in the USA only.
Fractures have been treated with immobilization, traction, amputation, and internal fixation throughout history. Immobilization by casting, bracing, or splinting a joint above and below the fracture was used for most long bone fractures.
Several studies have suggested that reduction and fixation of an Intracapsular fracture of the hip with multiple pins or screws is associated with a lower rate of morbidity and mortality than treatment with prosthetic replacement. With improved methods of fixation and a tendency toward earlier weight-bearing, internal fixation is believed to be a better mode of treatment for younger, more active patients.
On the other hand, the internal fixation procedure may result with number of possibilities for serious complications and biomechanical disadvantages, leading to the device failure. This led to a growing tendency to prefer total or partial hip replacement as the common treatment for intracapsular fracture, although the internal fixation is the favorable procedure in the professional literature.
OrthoMediTec has developed the WaisFix100i device, a new concept for Intracapsular Femoral Fracture Fixation and bone grafting using minimally invasive procedures. The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
The Internal Triangular Cage is inserted into the femoral neck as a strong, solid beam structure to guide and hold the screws in place. The cage supplies the structure to hold the bone graft and screws at the fracture site.
The objectives of this single arm, multi-center, prospective study, are to evaluate the safety and efficacy of using the WaisFix100i device in intracapsular femoral fracture fixation surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Intracapsular Femoral Fracture Fixation, Device: WaisFix100i for Intracapsular Femoral Fracture Fixation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male/Female with Intracapsular femoral fracture type Garden I-II and several III.
- Age 50 to 75.
- Subject able to comprehend and give informed consent for participation in this study.
Key exclusion criteria (8 listed)
- Known active infectious disease.
- Terminal diseases
- Patients in high risk and/or acute cardio-vascular disease.
- Known cognitive disorder, psychiatric and/or neurological disease
- Physician objection.
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 |
|---|---|---|
| Intracapsular Femoral Fracture FixationAlso: WaisFix100iThe WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws. | Device | A |
| WaisFix100i for Intracapsular Femoral Fracture FixationThe WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws. | Device | A |
Primary outcome
The safety endpoint is measure by paucity incidence of treatment related major complications.
Time frame: Study duration
1 secondary outcome
Efficacy endpoint is measure by the following: 1. A subject is scored a success if he had no revision surgery, hemi- arthroplasty or total hip replacement surgery by 12 months; 2. Time to functional recovery
Time frame: Study duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
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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.
Marc Waisman, Dr. principal investigator
Carmel medical Center, Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracapsular Femoral Fracture Fixation and WaisFix100i for Intracapsular Femoral Fracture Fixation in people with Hip Fracture, run by OrthoMediTec at 1 site 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 3 inclusion and 8 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: paused, as of the sponsor's last update on 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
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?
The safety endpoint is measure by paucity incidence of treatment related major complications. (time frame: Study duration). 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 12 Jan 2009.