Comparison of Treatment Outcomes in Hip Fractures Surgically Fixed With Either a Two or Four Hole Device.

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00323232
First received: May 8, 2006
Last updated: April 26, 2011
Last verified: April 2011
  Purpose

Although Standard of Care for Hip Fractures is the Device (Dynamic Hip Screw) being studied in this project, and both sizes (the 2 and the 4 hole versions) are currently in use there is not widespread agreement yet whether there is an optimal number of screws (2 or 4) required for the best outcomes. If it can be shown that a 2 hole version is just as successful in outcomes it would allow for a smaller incision (surgical cut) at the site of the fracture. This could reduce soft tissue dissection, operating time, and surgical blood loss. This in turn would reduce post operative pain, blood loss, and hospital length of stay.


Condition Intervention Phase
Hip Fracture
Device: 2 Versus 4 Hole DHS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two-Hole Versus Four-Hole Dynamic Hip Screw (DHS) for the Treatment of Intertrochanteric Fractures: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Mechanical failure of fixation (up to 6 months) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of incision, post-operative pain, analgesic use, operative time, and mean hemoglobin drop. Length of hospital stay and medical complications will also be assessed while hospitalized [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 2 Versus 4 Hole DHS
    See Detailed Description.
Detailed Description:

This study has been designed to prospectively evaluate the clinical results of a two-hole versus four-hole dynamic hip screw in the treatment of intertrochanteric fractures.

It is estimated that over 27,000 hip fractures occur in Canada each year, at an estimated cost of $10,000 per patient per hospitalization. Intertrochanteric hip fractures account for approximately half of all hip fractures. While many surgical treatment options exist, the accepted standard fixation device for the treatment of both stable and unstable intertrochanteric hip fractures is the dynamic hip screw.

No consensus exists regarding the optimal number of screws required for adequate side plate fixation for the treatment of intertrochanteric fractures. The most commonly used device is the 135-degree four-hole side plate, however, decreasing the length of the side plate would theoretically allow for a smaller incision site, minimal soft-tissue dissection, shortened operating time, and reduced operative blood loss. This in turn would reduce post-operative pain, blood loss, and length of hospital stay. With the majority of hip fractures occurring in the frail, elderly population, a less invasive procedure potentially decreases overall patient mortality.

Biomechanical studies simulating stable and unstable intertrochanteric fractures have suggested that fewer screws are adequate for good side plate fixation. Two clinical trials have reviewed series of fractures treated with a two-hole DHS and have reported favorable results. No prospective randomized study to date, however, has directly compared the clinical results of the standard four-hole plate with that of the two-hole plate. We propose a study is to evaluate the clinical results of the two-hole versus four-hole plate for the treatment of intertrochanteric fractures with a minimum 6-month follow-up.

This study's aim is to develop clinical outcome data which can be used (a) determine range of expected clinical outcomes resulting from current standard management of these injuries, and (b) as the basis of reporting on the clinical outcomes of these injuries in the peer-reviewed literature.

Patients over the age of 65 who have sustained an isolated 2-, 3-, and 4-part intertrochanteric hip fractures will be included in this study.

Patients who have Pathological, subtrochanteric, reverse obliquity fractures, multiple injuries, and patients whose time to the operating room exceeds 48 hours will be excluded.

The primary outcome measure to be assessed is mechanical failure of fixation. Secondary variables to be assessed during the hospital stay are: length of incision, post-operative pain, analgesic use, operative time, and mean hemoglobin drop. Length of hospital stay and medical complications will also be assessed.

They will subsequently be followed at six weeks, 3 months, and six months post-operatively in clinic with a physical exam and a pelvis and hip radiograph, and an inquiry will be made as to their general medical condition and any significant medical complications since discharge. A functional inquiry and quality of life score will be administered pre-operatively and at each subsequent clinic visit.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Consenting patients over the age of 65 with an isolated 2-, 3-, and 4-part intertrochanteric hip fractures will be included in this study.

Exclusion Criteria:

-

  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: NCT00323232

Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: P J O'Brien, MD The University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. P J O'Brien, University of British Columbia
ClinicalTrials.gov Identifier: NCT00323232     History of Changes
Other Study ID Numbers: C05-0441
Study First Received: May 8, 2006
Last Updated: April 26, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
DHS, Intertrochanteric

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

ClinicalTrials.gov processed this record on July 26, 2014