Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01578746|
Recruitment Status : Unknown
Verified June 2013 by Sorlandet Hospital HF.
Recruitment status was: Active, not recruiting
First Posted : April 17, 2012
Last Update Posted : June 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coxarthrosis||Procedure: Direct lateral approach in total hip arthroplasty Procedure: Anterior approach||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Direct lateral approach
Patient operated using direct lateral approach.
Procedure: Direct lateral approach in total hip arthroplasty
The use of direct lateral approach in total hip arthroplasty
Other Name: Hardinge approach
Active Comparator: Anterior approach
Patient operated using anterior approach.
Procedure: Anterior approach
The use of anterior approach in total hip arthroplasty
Other Name: Smith-Petersen approach
- Change in function [ Time Frame: 2 years ]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.
- Muscle damage [ Time Frame: Day of operation and next four consecutive days ]CK-total is measured direct postoperativly and for the next four consequtive days. CRP is measured the first four postoperative days.
- Pain [ Time Frame: First four postoperative days ]Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.
- X-ray assessment [ Time Frame: 3 and 12 months ]Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.
- MRI [ Time Frame: 3 and 12 months ]A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578746
|Sorlandet Hospital HF|
|Principal Investigator:||Svein Andreas Svenningsen, M.D, Ph.D||Sorlandet Hospital HF|