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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
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Coxarthrosis Procedure: Direct lateral approach in total hip arthroplasty Procedure: Anterior approach Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Pain [ Time Frame: First four postoperative days ]
    Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.

  3. X-ray assessment [ Time Frame: 3 and 12 months ]
    Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.

  4. 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.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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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


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

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01578746     History of Changes
Other Study ID Numbers: 811398
2011/2581 D ( Other Identifier: Regioal Ethics Commitee Norway )
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013

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