Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03673514
Other study ID # CÉR : 2009-09-67;2010-415
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT02818894 - Spinal Anesthesia in Total Hip Arthroplasty Phase 4
Completed NCT02242201 - Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular Phase 4
Completed NCT02414542 - Minima Clinical Study
Completed NCT01817010 - Strength and Function Following Total Hip Arthroplasty N/A
Completed NCT01443975 - Clinical Evaluation on the Use of the X-pander Device N/A
Recruiting NCT05530551 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA N/A
Recruiting NCT05530174 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture N/A
Recruiting NCT06141928 - Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty N/A
Recruiting NCT05054192 - Reliability and Validity of Modified Four Square Step Test
Recruiting NCT04492462 - The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery N/A
Withdrawn NCT02926651 - Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty Phase 4
Completed NCT02308813 - Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip N/A
Recruiting NCT02032017 - Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation. N/A
Recruiting NCT01312077 - The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement Phase 4
Withdrawn NCT01380665 - Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty Phase 4
Recruiting NCT05893563 - Corail Stability at 5-Years Post-Total Hip Arthroplasty
Recruiting NCT06088069 - Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty N/A
Active, not recruiting NCT03210844 - The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty N/A
Recruiting NCT04801680 - Mpact 3D Metal Cup PMS
Terminated NCT02006251 - Real-Time Instrument for Acetabular Shell Positioning