Clinical trial NCT03673514: Anterior vs Posterior Approach in THA
Official title: Direct Anterior Versus Posterior Approach for Total Hip Arthroplasty: a Multicentric Prospective Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Direct anterior approach
posterior approach
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital stay
timeFrame: Between 0 days and 1 month, average of 4 days
Secondary outcomes:
measure: functional recovery
timeFrame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
measure: pain assessment: VAS
timeFrame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
measure: implant position
timeFrame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
measure: number of patients with per/post surgical complications.
timeFrame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
measure: surgical time
timeFrame: Up to 240 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Moerenhout K, Derome P, Laflamme GY, Leduc S, Gaspard HS, Benoit B. Direct anterior versus posterior approach for total hip arthroplasty: a multicentre, prospective, randomized clinical trial. Can J Surg. 2020 Sep-Oct;63(5):E412-E417. doi: 10.1503/cjs.012019.