Prospective Catalystem CT-RSA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CATALYSTEM.
- Who it may be relevant to
- Registry conditions: Hip Osteoarthritis. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multi-center, Non-controlled, Prospective CT-based Radiostereometric Analysis of Catalystem Primary Hip System
Overview
Multi-Centre Study in patients undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.
Detailed description
This study is designed as a prospective, multi-center, non-controlled study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 2 years post-operatively.
Radiostereometric analysis (RSA) is a tool to measure implant migration, originally developed in the 1970s. It is now well-established that early migration (micromotion) of implants with respect to bone is a predictor for later aseptic loosening. Traditional RSA used dual x-ray to estimate implant migration and has been standardized. CT-based methods (CT-RSA), which do not require metal reference beads have been developed since, and have been validated with equivalent results. International guidelines have since been updated to reflect this move to CT-RSA.
The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.
Interventions
- Device CATALYSTEM
CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty
Primary outcome measures
- Migration - CATALYSTEM Stem [Time frame: 2 Years]
Secondary outcome measures (7)
- Subsidence - CATALYSTEM Stem [Time frame: 6 months and 1 Year]
- Other RSA measurements - CATALYSTEM stem [Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years]
- Oxford Hip Score [Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years]
- Forgotten Joint Score (FJS-12) [Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years]
- European Quality of Life (EQ-5D-5L) [Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years]
- Patient Satisfaction (VAS) [Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years]
- Complication [Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years]
Eligibility criteria
Inclusion criteria
- Patient requires primary unilateral THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital dysplasia.
- Patients is at least 21 years old at the time of informed consent.
- Patient is able to read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information for study purposes.
- Patient is able and willing to return for follow-up as specified by the study protocol.
- Patient is able and willing to complete the required questionnaires and patient-completed portions of the study protocol.
Exclusion criteria
- Patient requires implants other than the planned components or would not be a candidate for allowable components to be used (see 4) in the judgement of the surgeon.
- Patient is planned to have simultaneous bilateral hip arthroplasty
- Patient had contralateral hip arthroplasty less than 6 months prior to the day of surgery.
- Patient is expected to have contralateral hip arthroplasty in the following 6 months at the time of consent into this study.
- Patient has active local or systemic infection.
- Patient has amputations in either leg that would impact rehabilitation following surgery.
- Patient has loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
- Patient has poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis, or require additional fixation, or a significant chance of periprosthetic fracture, or the lack of adequate bone to support the implant(s).
- Patient has Charcot's or Paget's disease.
- Patient is pregnant or lactating.
- Patient is bedridden.
- Patient has participated in a clinical investigation with an investigational product (drug or device) in the last 3 months.
- Patient is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Patients is, in the opinion of the surgeon, a drug or alcohol abuser or has psychological disorder(s) that could affect their ability to complete patient-reported questionnaires or be compliant with follow-up requirements.
- Patient is diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Orthopaedic Innovation Centre — Winnipeg
Identifiers
NCT: NCT07698717 · #5179