Anterior vs Posterior Approach in 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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-01

Study Completion Date

2013-08-01

Brief Summary

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Determining the best approach for a total hip arthroplasty (THA) implies that the procedure is kind on soft tissues, with the lowest complication rates, and easily reproducible. Although there have been several attempts to resolve this issue in the last decade, a definitive answer has not been found. Therefore, the investigators performed a prospective study to compare direct anterior versus posterior approach based on (1) hospital stay, (2) functional outcome, (3) pain, (4) implant position (5) complications and (6) surgical time.

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Detailed Description

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In this multicentric, prospective, randomized clinical trial, 55 total hip arthroplasties were performed on 50 patients between February 2011 and July 2013. Patients meeting the inclusion criteria underwent surgical treatment using the DAA or PA, according to a randomization process. Radiological analysis assessed implant position, limb lengthening, and potential implant related complications. X-rays were performed at subsequent follow-up visits and consisted of an antero-posterior (AP) pelvic X-ray and a lateral projection of the hip. Two independent observers, not involved with patients or surgeries, reviewed all postoperative radiographs independently.Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study.

Patients underwent either the posterior or direct anterior approach.

Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

However, the decision to discharge subjects was made by physiotherapists blinded to treatment and based on objective criteria. These criteria were: 1) being autonomous for transfer from bed/chair to upright position 2) being able to walk with walking aid 3) climbing stairs in a safe way 4) having a pain level contained by painkillers. No restrictions were recommended for either group. The same rehabilitation and pain protocols were used for both approaches. In addition, statistical analyses were performed by an independent consultant who remained blinded to treatment group assignment.

Study Groups

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THA Posterior Approach

The posterior approach to the hip has been described by many authors and yields good results. Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing. All implants were non-cemented.

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type PROCEDURE

Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study

THA Direct anterior approach

The modified Hueter approach, based on the Smith-Peterson approach, was performed for the direct anterior minimally invasive surgery. This approach could have some advantages as it is a muscle sparing approach, hence yielding a faster recovery. A traction table was used for DAA as surgeons were trained to use this method. No intra-operative fluoroscopy was used for implant confirmation.Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing. All implants were non-cemented.

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type PROCEDURE

Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study

Interventions

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Total hip arthroplasty

Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary total hip replacement due to osteoarthrosis or osteonecrosis
* patients older than 50 years.

Exclusion Criteria

* inflammatory arthritis,
* any previous ipsilateral hip surgery
* suffering from proximal femoral deformity
* BMI over 40
* active infection
* severe contralateral hip disease, muscle contractures or neuromuscular pathology
* requiring structural bone grafts.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No