Arthroplasty, Replacement, Hip
Conditions
Keywords
DAA, SuperPATH, Direct Anterior Approach, THA
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.
Interventions
PROCEDUREDirect Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
PROCEDURESuperPATH
SuperPATH approach surgery to replace the hip.
Sponsors
MicroPort Orthopedics Inc.
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL) | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 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. |
| Change in Gait analysis | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | This is done by a biomechanics lab for a subsection of 30 patients to test their hip movements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Pain Score | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively. | 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. |
| Change in Complication rates | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | Complications such as fractures that the participant experiences will be assessed |
| Readmission rates | 3 months post-operatively | Any readmission rates for the participant |
| Change in EQ-5D-5L | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | 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. |
| Change in Timed-Stair-Climb (TSC) | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | The time it takes for a participant to go up and down a flight of 10 stairs. |
| Change in Range of Motion (ROM) | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | IR and ER ROM at flexion and extension, this is measured using a goniometer (which is an instrument that measures an angle). |
| Change in X-rays (AP pelvis & lateral) | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | To check how their bones are faring in their hip area |
| Change in Timed-up-and-go (TUG) | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively. | The time it takes for the participant to get up from a chair walk 3 metres forward and back and sit back down |
| Change in Pre-post Hgb | This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively. | Checks blood oxygen level |
Countries
Canada
Contacts
Primary ContactWade Gofton, MD, FRCSC
Backup ContactMeaghan Dufresne
Outcome results
None listed