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

Hip Fracture Clinical Trial

Official title:

Two-Hole Versus Four-Hole Dynamic Hip Screw (DHS) for the Treatment of Intertrochanteric Fractures: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323232
• Other study ID #: C05-0441
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2006
• Last updated: April 26, 2011
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Device:
• 2 Versus 4 Hole DHS
See Detailed Description.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical failure of fixation (up to 6 months)		Unspecified	No
Secondary	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		Unspecified	No