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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Unilateral Primary Osteoarthritis of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Modified direct lateral approach

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

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type PROCEDURE

The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

Posterior approach

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

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type PROCEDURE

The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

Interventions

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Total hip arthroplasty

The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes