A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-12-31

Brief Summary

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This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.

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Detailed Description

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Conditions

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Osteoarthritis Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anterior Approach Group

(AMIS)

Group Type ACTIVE_COMPARATOR

Minimally Invasive Anterior Approach

Intervention Type PROCEDURE

Anterior minimally invasive surgery (AMIS)

Posterior Approach Group

(Posterior)

Group Type ACTIVE_COMPARATOR

Standard postero-lateral approach

Intervention Type PROCEDURE

Interventions

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Minimally Invasive Anterior Approach

Anterior minimally invasive surgery (AMIS)

Intervention Type PROCEDURE

Standard postero-lateral approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Males and females aged 18-75 years at time of surgery.
* Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.
* Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
* Patients who signed the study consent form prior to surgery.

Exclusion Criteria

* Pregnant women or women who plan to conceive in the future.
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
* Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).
* Those with co-existent ipsilateral knee disease or back problems
* Muscle contracture around the hip joint
* Individuals who have undergone organ transplant.
* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
* Individuals who have had a THR on the contra-lateral side within the 6 months.
* Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) \< 16 points.
* Individuals requiring bilateral hip replacement.
* Individuals whose body mass index (BMI; kg/m2) \>35.
* Individuals with active or suspected infection or sepsis.
* Individuals with renal failure and/or renal insufficiency.
* Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No