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Hip FracturePhase 4NCT00323232

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

A Phase 4 study testing 2 Versus 4 Hole DHS in people with Hip Fracture, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hip Fracture
What is being tested?
2 Versus 4 Hole DHS
Type of treatment
Medical device
How many people
400 participants
Where
1 siteCanada
Study dates
Dec 2010to Apr 2011
Phase
Phase 4
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Vancouver General Hospital

    Vancouver, British Columbia

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Hip Fracture
Being tested
2 Versus 4 Hole DHS
Keywords
DHS, Intertrochanteric
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2 Versus 4 Hole DHSDevice

    See Detailed Description.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mechanical failure of fixation (up to 6 months)

Secondary outcomes (1)
  1. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2006 (estimated)
  2. Study startDec 2010
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323232
Sponsor's protocol ID
C05-0441
Status last verified
Apr 2011
First submitted
8 May 2006
Last updated
27 Apr 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 2 Versus 4 Hole DHS in people with Hip Fracture, run by University of British Columbia at 1 site in Canada.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Apr 2011. 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 Canada. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mechanical failure of fixation (up to 6 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 Apr 2011.

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