SuperPath Versus Posterior Approach for THA

NCT05147207 | Completed Phase 4

• 1 other identifier: SURG-387-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Approach; Hip Arthropathy

Outcome Measures

Primary Outcomes (2)

• Functional Outcomes TUG

  Timed up and go test

  6 weeks

• Functional Outcomes TSC

  Timed stair climb

  6 weeks

Secondary Outcomes (2)

• Subjective Measure

  3 months

• Pain Score

  1 month

Study Arms (2)

Superpath

EXPERIMENTAL

This is a minimally invasive surgical approach.

Procedure: Superpath Approach

Posterior Approach

NO INTERVENTION

This is the traditional THA surgical approach used.

Interventions

Superpath Approach PROCEDURE

This is a minimally invasive surgical approach for THA.

Superpath

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• 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.

  PMID: 36350098 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: superpath approach versus posterior approach

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 7, 2021
• Study Start: April 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)