Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01578746
First received: March 13, 2012
Last updated: June 13, 2013
Last verified: June 2013

March 13, 2012
June 13, 2013
January 2012
December 2016   (final data collection date for primary outcome measure)
Change in function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01578746 on ClinicalTrials.gov Archive Site
  • Muscle damage [ Time Frame: Day of operation and next four consecutive days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.
  • MRI [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage.
Same as current
Not Provided
Not Provided
 
Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coxarthrosis
  • Procedure: Direct lateral approach in total hip arthroplasty
    The use of direct lateral approach in total hip arthroplasty
    Other Name: Hardinge approach
  • Procedure: Anterior approach
    The use of anterior approach in total hip arthroplasty
    Other Name: Smith-Petersen approach
  • Active Comparator: Direct lateral approach
    Patient operated using direct lateral approach.
    Intervention: Procedure: Direct lateral approach in total hip arthroplasty
  • Active Comparator: Anterior approach
    Patient operated using anterior approach.
    Intervention: Procedure: Anterior approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria:

  • Previous surgery on affected hip
  • No mental disability preventing follow-up
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01578746
811398, 2011/2581 D
Yes
Sorlandet Hospital HF
Sorlandet Hospital HF
Not Provided
Principal Investigator: Svein Andreas Svenningsen, M.D, Ph.D Sorlandet Hospital HF
Sorlandet Hospital HF
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP