SuperPath Versus Posterior Approach for THA | NCT05147207

Studies
SuperPath Versus Posterior Approach for THA

NCT05147207

Sponsor

Queen's University

Status

Completed

Last Update Posted

Apr 20, 2022Actual

Enrollment

45Actual

Phase

Phase 4

Conditions

Surgical Approach
Hip Arthropathy

Interventions

Superpath Approach

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Oct 20, 2021

First Submission Date that Met QC Criteria

Nov 23, 2021

First Posted Date

Dec 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2022

Last Update Posted Date

Apr 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Superpath Approach	Procedure	This is a minimally invasive surgical approach for THA.	Superpath

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Kingston General Hospital		Kingston	Ontario	K7L 2V7	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36350098	Derived	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.