Clinical trial NCT03746925: Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches
Official title: Randomized Control Trial Comparing Short-term Outcomes After Direct Anterior and SuperPATH Approaches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: DAA
SuperPATH
Direct Anterior Approach
THA
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: MicroPort Orthopedics Inc.
First posted: 2018-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
measure: Change in Gait analysis
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary outcomes:
measure: Change in EQ-5D-5L
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
measure: Change in Pre-post Hgb
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
measure: Change in Visual Analog Scale (VAS) Pain Score
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
measure: Change in Complication rates
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
measure: Readmission rates
timeFrame: 3 months post-operatively
measure: Change in Timed-up-and-go (TUG)
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
measure: Change in Timed-Stair-Climb (TSC)
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
measure: Change in Range of Motion (ROM)
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
measure: Change in X-rays (AP pelvis & lateral)
timeFrame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Wade Gofton, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
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