SuperPath Versus Posterior Approach for THA

NCT ID: NCT05147207

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-06-01

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.

Conditions

Surgical Approach; Hip Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Superpath

This is a minimally invasive surgical approach.

Group Type: EXPERIMENTAL

Superpath Approach

Intervention Type: PROCEDURE

This is a minimally invasive surgical approach for THA.

Posterior Approach

This is the traditional THA surgical approach used.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Superpath Approach

This is a minimally invasive surgical approach for THA.

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gavin Wood

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36350098 (View on PubMed)

Other Identifiers

SURG-387-17

Identifier Type: -

Identifier Source: org_study_id