Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
|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.
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|