Anterior vs Posterior Approach in THA

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673514
• Other study ID #: CÉR : 2009-09-67;2010-415
• Status: Completed
• Phase: N/A
• Start date: February 1, 2011
• Est. completion date: August 1, 2013

Study information

• Verified date: September 2018
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1, 2013
• Est. primary completion date: July 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital stay	Length in days of hospital stay	Between 0 days and 1 month, average of 4 days
Secondary	functional recovery	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
Secondary	pain assessment: VAS	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
Secondary	implant position	Radiological assessment	2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
Secondary	number of patients with per/post surgical complications.	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
Secondary	surgical time	Surgical time in minutes	Up to 240 minutes