Clinical trial NCT04879732: RSA - ACTIS Hip Stem
Official title: Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2021-05-10
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The principal objective of this study is to compare mean 2-year subsidence of the ACTIS femoral stem using model-based RSA against published migration patterns for hip stems of a similar design. Secondary objectives include comparison of migration per surgical approach, quantifying changes in functional and health status of subjects following surgery, and assess occurrences of complications and adverse events.

Detailed description: This is a multi-centre, sequential enrollment trial of patients undergoing primary total hip arthroplasty. Patients will be recruited at three Canadian Centres to receive the ACTIS femoral hip stem via 3 different surgical approaches.

Model-based RSA will identify migration of the implant with respect to the femoral bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals to quantify improvement as a result of the surgery and trajectory of recovery. Adverse events and clinical complications in each study group will be captured and compared. Select surgical, hospital and rehabilitation data will be collected to measure health economic outcomes relating to the surgery.

Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
* Aged 21 years or older
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent
* Body mass index ≤45 kg/m2

Exclusion Criteria

* Active or prior infection
* Medical condition precluding major surgery
* Medical condition with less than 2 years life expectancy
* Overhanging pannus (for anterior approach cohort only)
* Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
* Skin condition on the area of incision
* Multi-level lumbar spine fusion
* Ankylosing spondylolithesis
* Shortening osteotomy through the femur

Primary outcomes:
measure: Subsidence of the ACTIS femoral stem
timeFrame: 2 Year
Secondary outcomes:
measure: Comparison of migration per surgical approach
timeFrame: 2 Year
measure: Oxford Hip Score (OHS)
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: European Quality of Life (EQ-5D-5L) questionnaire
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: Visual analogue scale (VAS) for thigh pain
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: Visual analogue scale (VAS) for satisfaction
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: University of California at Los Angeles (UCLA) Activity Level scale
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Orthopaedic Innovation Centre
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health - Orthopedic
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Manitoba
name: Thomas Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: