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SuperPath Versus Posterior Approach for THA

Primary Purpose

Surgical Approach, Hip Arthropathy

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Superpath Approach

About this trial

This is an interventional treatment trial for Surgical Approach

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Superpath

Posterior Approach

Arm Description

This is a minimally invasive surgical approach.

This is the traditional THA surgical approach used.

Outcomes

Primary Outcome Measures

Functional Outcomes TUG

Timed up and go test

Functional Outcomes TSC

Timed stair climb

Secondary Outcome Measures

Subjective Measure

Oxford Hip Score - score from 0 (severe hip arthritis) to 48 (satisfactory joint function)

Pain Score

Visual Analog Scale - score from 0 (no pain) to 10 (worst pain)

Full Information

NCT ID

NCT05147207

First Posted

October 20, 2021

Last Updated

April 13, 2022

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT05147207

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Approach, Hip Arthropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

superpath approach versus posterior approach

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Superpath

Arm Type

Experimental

Arm Description

This is a minimally invasive surgical approach.

Arm Title

Posterior Approach

Arm Type

No Intervention

Arm Description

This is the traditional THA surgical approach used.

Intervention Type

Procedure

Intervention Name(s)

Superpath Approach

Intervention Description

This is a minimally invasive surgical approach for THA.

Primary Outcome Measure Information:

Title

Functional Outcomes TUG

Description

Timed up and go test

Time Frame

6 weeks

Title

Functional Outcomes TSC

Description

Timed stair climb

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Subjective Measure

Description

Oxford Hip Score - score from 0 (severe hip arthritis) to 48 (satisfactory joint function)

Time Frame

3 months

Title

Pain Score

Description

Visual Analog Scale - score from 0 (no pain) to 10 (worst pain)

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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;

Facility Information:

Facility Name

Kingston General Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36350098

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.

Results Reference

derived

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SuperPath Versus Posterior Approach for THA

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