Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty

NCT01578746 | Unknown Phase 4 DMC

• 2 other identifiers: 8113982011/2581 D
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Coxarthrosis

Keywords

Coxarthrosis; Hip arthroplasty; Anterior approach; Direct lateral approach; Hardinge approach; Smith-Petersen approach; Osteoarthrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Muscle damage

  Day of operation and next four consecutive days

• Pain

  First four postoperative days

• X-ray assessment

  3 and 12 months

• MRI

  3 and 12 months

Study Arms (2)

Direct lateral approach

ACTIVE COMPARATOR

Patient operated using direct lateral approach.

Procedure: Direct lateral approach in total hip arthroplasty

Anterior approach

ACTIVE COMPARATOR

Patient operated using anterior approach.

Procedure: Anterior approach

Interventions

Direct lateral approach in total hip arthroplasty PROCEDURE

The use of direct lateral approach in total hip arthroplasty

Also known as: Hardinge approach

Direct lateral approach

Anterior approach PROCEDURE

The use of anterior approach in total hip arthroplasty

Also known as: Smith-Petersen approach

Anterior approach

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiological diagnosis of coxarthrosis

You may not qualify if:

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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Hospital HF

Arendal, Norway

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Svein Andreas Svenningsen, M.D, Ph.D

  Sorlandet Hospital HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: April 17, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 14, 2013

Record last verified: 2013-06

Locations

NO (1)