Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA (COMPALA)

Odense University Hospital

Status and phase: Completed; Phase 2

Conditions: Unilateral Primary Osteoarthritis of Hip

Treatments: Procedure: Total hip arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01616667

A2116 Signe Rosenlund (Other Identifier)

S-20120009

11/28589 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.

Enrollment: 80 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 45-70 years, both included.
• Patients schedule for primary cementless total hip arthroplasty.
• Endstage hip osteoarthritis(OA) or minor dysplasia of the hip(CE-angle > 20 degrees).

Exclusion criteria

1. more major joint (hip or knee) than the current hip affected with OA, with expected joint replacement surgery within a year.
2. Prior joint replacement surgery on any major joint (hip, knee) in lower limb.
3. BMI above 35.
4. Any physical disability that prevents patients from walking 20 meters without aid.
5. The patients is not suitable for standard cementless prosthetic components.
6. Any neurological disease (ex. cerebral thrombosis, Parkinson) compromising the walking ability.
7. Any severe medical condition compromising walking ability (ex. chronic heart failure, chronic obstructive pulmonary disease).
8. Severe dementia.
9. Inability to read and understand Danish writing and oral instructions.
10. Do not want to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Modified direct lateral approach

Active Comparator group

Description:

The patients included is operated with a total hip arthroplasty using a modified direct lateral approach

Treatment:

Procedure: Total hip arthroplasty

Posterior approach

Active Comparator group

Description:

The patients included is operated with a total hip arthroplasty using posterior approach

Treatment:

Procedure: Total hip arthroplasty