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Completed

NCT Number: NCT03673514

Anterior vs Posterior Approach in THA

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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Key information

Conditions

Total Hip Arthroplasty

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Hip Arthroplasty

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

Primary outcomes

  1. Hospital stay

    Time frame: Between 0 days and 1 month, average of 4 days

    Length in days of hospital stay

Secondary outcomes

  1. 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. 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.

  3. implant position

    Time frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively

    Radiological assessment

  4. 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.

  5. surgical time

    Time frame: Up to 240 minutes

    Surgical time in minutes

Sponsors and collaborators

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2018
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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