Back to resultsComparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
Primary Purpose
Coxarthrosis
Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Direct lateral approach in total hip arthroplasty
Anterior approach
Sponsored by
About this trial
This is an interventional treatment trial for Coxarthrosis focused on measuring Coxarthrosis, Hip arthroplasty, Anterior approach, Direct lateral approach, Hardinge approach, Smith-Petersen approach, Osteoarthrosis
Eligibility Criteria
Inclusion Criteria:
- Clinical and radiological diagnosis of coxarthrosis
Exclusion Criteria:
- Previous surgery on affected hip
- No mental disability preventing follow-up
Sites / Locations
- Sorlandet Hospital HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Direct lateral approach
Anterior approach
Arm Description
Patient operated using direct lateral approach.
Patient operated using anterior approach.
Outcomes
Primary Outcome Measures
Change in function
Function of the operated hip will be evaluated after 3, 6, 12 and 24 months using Oxford Hip Score, Harris Hip Score and 6-minute-walk-test. Improvement in general health will be evaluated by using Eq-5D.
Secondary Outcome Measures
Muscle damage
CK-total is measured direct postoperativly and for the next four consequtive days. CRP is measured the first four postoperative days.
Pain
Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.
X-ray assessment
Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.
MRI
A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01578746
Brief Title
Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
Official Title
Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In total hip arthroplasty several approaches can be used. The newly introduced minimally invasive anterior approach is supposed to cause less damage to tendons and muscles. At the same time there are reports that there are more complications when this approach is used. The direct lateral approach is the most used in Norway and is well documented. There are however those who postulate that there is to high risk of damage to the gluteus medius causing Trendelenburg gait. In the investigators hospital both the anterior and direct lateral approach is used with good result. The investigators main study hypothesis is that there is no difference between the use of anterior or direct lateral approach i total hip arthroplasty in regards to postoperative function and pain, complications, radiological finds (X-ray and MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
Coxarthrosis, Hip arthroplasty, Anterior approach, Direct lateral approach, Hardinge approach, Smith-Petersen approach, Osteoarthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Direct lateral approach
Arm Type
Active Comparator
Arm Description
Patient operated using direct lateral approach.
Arm Title
Anterior approach
Arm Type
Active Comparator
Arm Description
Patient operated using anterior approach.
Intervention Type
Procedure
Intervention Name(s)
Direct lateral approach in total hip arthroplasty
Other Intervention Name(s)
Hardinge approach
Intervention Description
The use of direct lateral approach in total hip arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Anterior approach
Other Intervention Name(s)
Smith-Petersen approach
Intervention Description
The use of anterior approach in total hip arthroplasty
Primary Outcome Measure Information:
Title
Change in function
Description
Function of the operated hip will be evaluated after 3, 6, 12 and 24 months using Oxford Hip Score, Harris Hip Score and 6-minute-walk-test. Improvement in general health will be evaluated by using Eq-5D.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Muscle damage
Description
CK-total is measured direct postoperativly and for the next four consequtive days. CRP is measured the first four postoperative days.
Time Frame
Day of operation and next four consecutive days
Title
Pain
Description
Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.
Time Frame
First four postoperative days
Title
X-ray assessment
Description
Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.
Time Frame
3 and 12 months
Title
MRI
Description
A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage.
Time Frame
3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and radiological diagnosis of coxarthrosis
Exclusion Criteria:
Previous surgery on affected hip
No mental disability preventing follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svein Andreas Svenningsen, M.D, Ph.D
Organizational Affiliation
Sorlandet Hospital HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital HF
City
Arendal
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
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