Recruiting

Direct Anterior vs. SuperPATH

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03746925

Conditions

Arthroplasty, Replacement, Hip

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Direct Anterior Approach (DAA)

SuperPATH

Study Details

Brief summary:

This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. DAA approach has been used for many years, but it has a high learning curve and can be difficult for doctors to use, it is however linked with fewer complications when performed by an experienced doctor. SuperPATH is a newer technique which has been shown in studies to be adopted with less complications even during the learning phase. It also shows cost-saving results, showing a reduced length of stay for patients and better 30-day readmission rates. There is pressure on surgeons, from both patients and administration to use techniques that spare tissue, offer early functionality without compromising long-term outcomes. The SuperPATH can meet this benchmark but uptake has been slow, the investigators believe that it is due to the learning curve shown by this approach. The senior surgeon at The Ottawa Hospital is experienced in both techniques, using a trial the investigators can compare the two techniques and help encourage surgeons to change to a procedure that has demonstrated a low complication profile.

Conditions

Arthroplasty, Replacement, Hip

Study ID

NCT03746925

Start date

Sep 7, 2019

Status verified date

Aug, 2022

Completion date

Apr 7, 2023

Anticipated

Primary completion date

Jan 7, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing unilateral THA
  • Over 18 years of age and below 80
  • Subject is willing and able to complete required study visits and assessments
  • Subject is willing to sign the approved informed consent form

Exclusion Criteria:

  • Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0kg/m2 and 102.0cm, respectively for men, and 35.0kg/m2 and 88.0cm, respectively for women at screening
  • Subject is currently enrolled in another clinical investigation related to lower limbs, which could affect the endpoints of this protocol
  • Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
  • Subject is currently incarcerated or has impending incarceration
  • Previous hip surgery or infection on ipsilateral hip

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Direct Anterior Approach (DAA)

Direct Anterior Approach surgery to replace the hip.

experimental: SuperPATH

SuperPATH approach surgery to replace the hip.

Interventions

Direct Anterior Approach (DAA)

Direct Anterior Approach surgery to replace the hip.

SuperPATH

SuperPATH approach surgery to replace the hip.

Primary outcome measure

  • Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL) [ Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. ]
  • Change in Gait analysis [ Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. ]

Central Contacts and Locations

Central contacts

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Johanna Dobransky

jdobransky@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Aug 8, 2022

Last verified

Aug, 2022

Keywords

  • DAA
  • SuperPATH
  • Direct Anterior Approach
  • THA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-08-08.