Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation

This study has suspended participant recruitment.
Sponsor:
Information provided by:
OrthoMediTec
ClinicalTrials.gov Identifier:
NCT00521716
First received: August 26, 2007
Last updated: January 9, 2009
Last verified: February 2008
  Purpose

The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.


Condition Intervention
Hip Fracture
Device: Intracapsular Femoral Fracture Fixation
Device: WaisFix100i for Intracapsular Femoral Fracture Fixation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Uni-Center, Prospective Clinical Investigation to Evaluate Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation

Resource links provided by NLM:


Further study details as provided by OrthoMediTec:

Primary Outcome Measures:
  • The safety endpoint is measure by paucity incidence of treatment related major complications. [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Intracapsular Femoral Fracture Fixation
The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
Other Name: WaisFix100i
Device: WaisFix100i for Intracapsular Femoral Fracture Fixation
The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male/Female with Intracapsular femoral fracture type Garden I-II and several III.
  2. Age 50 to 75.
  3. Subject able to comprehend and give informed consent for participation in this study.

Exclusion Criteria:

  1. Known active infectious disease.
  2. Terminal diseases
  3. Patients in high risk and/or acute cardio-vascular disease.
  4. Known cognitive disorder, psychiatric and/or neurological disease
  5. Physician objection.
  6. Age under 50 or above 75.
  7. Concurrent participation in any other clinical study
  8. Patients cannot understand or not willing to sign the informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521716

Locations
Israel
carmel Medical Center
Haifa, Israel
Sponsors and Collaborators
OrthoMediTec
Investigators
Principal Investigator: Marc Waisman, Dr. Carmel medical Center, Haifa Israel
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, OrthoMediTec
ClinicalTrials.gov Identifier: NCT00521716     History of Changes
Other Study ID Numbers: WF-01
Study First Received: August 26, 2007
Last Updated: January 9, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by OrthoMediTec:
Hip Prosthesis Implantation

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Hip Fractures
Wounds and Injuries
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on August 26, 2014