Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Control Trial Comparing Short-term Outcomes After Direct Anterior and SuperPATH Approaches

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Procedure: Direct Anterior Approach (DAA)
* Procedure: SuperPATH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a 2 group, parallel study where they will be randomized into one of the two groups. One will receive SuperPATH approach and the other will receive DAA.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Anterior Approach (DAA)<br>Direct Anterior Approach surgery to replace the hip. | Procedure: Direct Anterior Approach (DAA)<br>* Direct Anterior Approach surgery to replace the hip.<br>|
| Experimental: SuperPATH<br>SuperPATH approach surgery to replace the hip. | Procedure: SuperPATH<br>* SuperPATH approach surgery to replace the hip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL) | This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score. | 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 | This is done by a biomechanics lab for a subsection of 30 patients to test their hip movements. | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EQ-5D-5L | Generic health status. Each question is scored from 1-5, with 1 being no problems and 5 being severe problems. These scores are not aggregated. There are 5 questions, mobility, self-care, usual activities, pain and anxiety. The last page is asking the participant to self score their health that day out of 100. | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 
| Change in Pre-post Hgb | Checks blood oxygen level | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively. | 
| Change in Visual Analog Scale (VAS) Pain Score | To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long. | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively. | 
| Change in Complication rates | Complications such as fractures that the participant experiences will be assessed | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 
| Readmission rates | Any readmission rates for the participant | 3 months post-operatively | 
| Change in Timed-up-and-go (TUG) | The time it takes for the participant to get up from a chair walk 3 metres forward and back and sit back down | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 
| Change in Timed-Stair-Climb (TSC) | The time it takes for a participant to go up and down a flight of 10 stairs. | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 
| Change in Range of Motion (ROM) | IR and ER ROM at flexion and extension, this is measured using a goniometer (which is an instrument that measures an angle). | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 
| Change in X-rays (AP pelvis & lateral) | To check how their bones are faring in their hip area | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAA, SuperPATH, Direct Anterior Approach, THA