SuperPath Versus Posterior Approach for THA

Hip Arthropathy Clinical Trial

Official title:

Supercapsular Percutaneously-Assisted Total Hip (SuperPATH®) Versus Conventional Posterior Approach for Total Hip Arthroplasty: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05147207
• Other study ID #: SURG-387-17
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2022
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases
• Surgical Approach

Intervention

Procedure:
• Superpath Approach
This is a minimally invasive surgical approach for THA.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcomes TUG	Timed up and go test	6 weeks
Primary	Functional Outcomes TSC	Timed stair climb	6 weeks
Secondary	Subjective Measure	Oxford Hip Score - score from 0 (severe hip arthritis) to 48 (satisfactory joint function)	3 months
Secondary	Pain Score	Visual Analog Scale - score from 0 (no pain) to 10 (worst pain)	1 month