Clinical trial NCT05147207: SuperPath Versus Posterior Approach for THA
Official title: Supercapsular Percutaneously-Assisted Total Hip (SuperPATH®) Versus Conventional Posterior Approach for Total Hip Arthroplasty: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Approach
Hip Arthropathy
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: superpath approach versus posterior approach
Primary purpose: TREATMENT

Brief summary: The SuperPATH approach is a minimally invasive approach for total hip arthroplasty. This project randomized patients to the SuperPath versus posterior approach. Outcomes examined included functional, VAS pain, narcotic utilization, perioperative outcomes, and radiographic component positions. Participants were followed for 2 years. The aim was to examine if the SuperPATH approach provided significant advantages over the posterior approach on functional testing or return to work for patients.

Detailed description: Background: The Supercapsular Percutaneously-Assisted Total Hip (SuperPATH) approach is a minimally invasive approach for total hip arthroplasty. It has been reported to show earlier mobilization, better gait kinematics, and short hospital length of stay. Our primary objective was to compare functional tests of timed up and go and timed stair climb preoperatively, at discharge, 2 weeks, and 6 weeks postoperatively. Secondary objectives included the return to function in weeks, Oxford hip scores, visual analog scale, narcotic utilization, perioperative outcomes, and radiographic component positions.

Methods: Forty-six patients were randomized into two groups on the surgery day: the SuperPATH group (25 patients) and the Posterior group (20 patients). Outcomes examined included functional, VAS pain, narcotic utilization, perioperative outcomes, and radiographic component positions.

Eligibility criteria: Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
* Inflammatory degenerative joint disease including rheumatoid arthritis;
* Correction of functional deformity.
* Subject is skeletally mature (21 years of age or older);
* Subject is a candidate to be implanted with the specified combination of components;
* Subject is willing and able to complete required study visits and assessments;
* Subject plans to be available through the follow-up visits;
* Subject is willing to sign the approved informed consent document.
* Subjects with a previous THA in the contralateral hip are eligible for enrollment provided it has been at least 1 year since the contralateral THA and the contralateral THA is asymptomatic and not pending revision. Simultaneous bilateral THA subjects will not be permitted to enroll.

Exclusion Criteria:

* Subject has overt infection or distant foci of infections;
* Subject has rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
* Subject with inadequate neuromuscular status (e.g. prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
* Subject has a neuropathic joints;
* Subject has hepatitis or HIV infection;
* Subject has a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing;
* Subject is currently enrolled in another clinical investigation that could affect the endpoints of this study;
* Subject is unwilling or unable to sign the informed consent document;
* Subject has documented substance abuse issues;
* Subject has a body mass index (BMI) of greater than 40;

Primary outcomes:
measure: Functional Outcomes TUG
timeFrame: 6 weeks
measure: Functional Outcomes TSC
timeFrame: 6 weeks
Secondary outcomes:
measure: Subjective Measure
timeFrame: 3 months
measure: Pain Score
timeFrame: 1 month
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
References:
citation: Khoja YT, Habis AA, Wood GCA. The Supercapsular Percutaneously Assisted Total Hip Approach Does Not Provide Any Clinical Advantage Over the Conventional Posterior Approach for THA in a Randomized Clinical Trial. Clin Orthop Relat Res. 2023 Jun 1;481(6):1116-1125. doi: 10.1097/CORR.0000000000002449. Epub 2022 Nov 8.