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.

Study Overview

• Status: Unknown
• Conditions: Coxarthrosis
• Intervention / Treatment: Procedure: Direct lateral approach in total hip arthroplasty; Procedure: Anterior approach

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Arendal, Norway
    • Sorlandet Hospital HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria:

• Previous surgery on affected hip
• No mental disability preventing follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Hardinge approach
ACTIVE_COMPARATOR: Anterior approach; Patient operated using anterior approach.	Procedure: Anterior approach; The use of anterior approach in total hip arthroplasty; Other Names: Smith-Petersen approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pain	Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.	First four postoperative days
X-ray assessment	Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.	3 and 12 months
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

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Investigators: Principal Investigator: Svein Andreas Svenningsen, M.D, Ph.D, Sorlandet Hospital HF

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (ESTIMATE): April 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 14, 2013
• Last Update Submitted That Met QC Criteria: June 13, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Hip arthroplasty; Osteoarthrosis; Coxarthrosis; Anterior approach; Direct lateral approach; Hardinge approach; Smith-Petersen approach
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 811398; 2011/2581 D (OTHER: Regioal Ethics Commitee Norway)