Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty

Coxarthrosis Clinical Trial

Official title:

Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01578746
• Other study ID #: 811398
• Secondary ID: 2011/2581 D
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 13, 2012
• Last updated: June 13, 2013
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2013
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria:

• Previous surgery on affected hip

• No mental disability preventing follow-up

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

Procedure:
• Direct lateral approach in total hip arthroplasty
The use of direct lateral approach in total hip arthroplasty
• Anterior approach
The use of anterior approach in total hip arthroplasty

Locations

Country	Name	City	State
Norway	Sorlandet Hospital HF	Arendal

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in function	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.	2 years	No
Secondary	Muscle damage	CK-total is measured direct postoperativly and for the next four consequtive days. CRP is measured the first four postoperative days.	Day of operation and next four consecutive days	No
Secondary	Pain	Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.	First four postoperative days	No
Secondary	X-ray assessment	Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.	3 and 12 months	No
Secondary	MRI	A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage.	3 and 12 months	No