SuperPath Versus Posterior Approach for THA

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Arthropathy; Surgical Approach
• Intervention / Treatment: Procedure: Superpath Approach

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Superpath; This is a minimally invasive surgical approach.	Procedure: Superpath Approach; This is a minimally invasive surgical approach for THA.
NO_INTERVENTION: Posterior Approach; This is the traditional THA surgical approach used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcomes TUG	Timed up and go test	6 weeks
Functional Outcomes TSC	Timed stair climb	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Measure	Oxford Hip Score - score from 0 (severe hip arthritis) to 48 (satisfactory joint function)	3 months
Pain Score	Visual Analog Scale - score from 0 (no pain) to 10 (worst pain)	1 month

Collaborators and Investigators

• Sponsor: Queen's University

Publications and helpful links

General Publications

• 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. 2022 Nov 18. doi: 10.1097/CORR.0000000000002449. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (ACTUAL): December 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: SURG-387-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No