Anterior vs Posterior Approach in THA

September 18, 2018 updated by: Kevin Moerenhout, Hopital du Sacre-Coeur de Montreal

Direct Anterior Versus Posterior Approach for Total Hip Arthroplasty: a Multicentric Prospective Randomized Clinical Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
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
ACTIVE_COMPARATOR: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: Between 0 days and 1 month, average of 4 days
Length in days of hospital stay
Between 0 days and 1 month, average of 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional recovery
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
The Harris Hip Score (HHS) was used to measure pain and function.Grading for the Harris Hip Score is interpreted on a scale of 0 to 100 as follows: results <70 are Poor; 70 - 79 are Fair; 80-89 are Good; 90 -100 are Excellent
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
pain assessment: VAS
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
Visual Analog Scale (VAS) was used. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The pain VAS is a single-item scale, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) . It is one total score, without subscale. As the lowest score of zero means no pain, it is the best possible outcome. As the highest score of 100 means the worst imaginable pain, it is the worst possible outcome.
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
implant position
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
Radiological assessment
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
number of patients with per/post surgical complications.
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
Possible complications are: peroperative fracture, hip dislocation, infection, neurologic complication, vascular complication or hematoma.
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
surgical time
Time Frame: Up to 240 minutes
Surgical time in minutes
Up to 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (ACTUAL)

September 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CÉR : 2009-09-67;2010-415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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