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
  Purpose

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.


Condition Intervention Phase
Coxarthrosis
Procedure: Direct lateral approach in total hip arthroplasty
Procedure: Anterior approach
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria:

  • Previous surgery on affected hip
  • No mental disability preventing follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578746

Locations
Norway
Sorlandet Hospital HF
Arendal, Norway
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Svein Andreas Svenningsen, M.D, Ph.D Sorlandet Hospital HF
  More Information

No publications provided

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01578746     History of Changes
Other Study ID Numbers: 811398, 2011/2581 D
Study First Received: March 13, 2012
Last Updated: June 13, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Sorlandet Hospital HF:
Coxarthrosis
Hip arthroplasty
Anterior approach
Direct lateral approach
Hardinge approach
Smith-Petersen approach
Osteoarthrosis

Additional relevant MeSH terms:
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014