Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323232
Status:
COMPLETED
Last Update Posted:
2011-04-27
First Post:
2006-05-08
Brief Title:
Comparison of Treatment Outcomes in Hip Fractures Surgically Fixed With Either a Two or Four Hole Device
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Two-Hole Versus Four-Hole Dynamic Hip Screw DHS for the Treatment of Intertrochanteric Fractures A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 27000 hip fractures occur in Canada each year at an estimated cost of 10000 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 studys 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
It is estimated that over 27000 hip fractures occur in Canada each year at an estimated cost of 10000 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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None