Clinical trial NCT04541693: REDAPT Revision Hip System With RSA
Official title: Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Orthopaedic Innovation Centre
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).

Detailed description: This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are:

1. femoral stem revision (n=30 hips)
2. acetabular cup revision (n=22 hips)

Eligibility criteria: Inclusion Criteria:

* Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised
* Ability to use study device (not requiring specialized implants)
* Patients between the ages of 18+ older
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Acute infection requiring washout, debridement, and liner exchange
* Unresolved infection
* Undergoing stage 1 of a 2-stage revision for infection
* Known metal allergy to device components
* Active participation in another clinical study (within the past 30 days)
* Known risk for loss to follow-up (significant geographical distance from treatment centre)
* BMI\>40 (severe obesity)
* Unable to provide informed consent (cognitive impairment)
* Patients requiring a bearing couple different than metal on polyethylene
* Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length)
* Patients with severe defects, dysplasia, or tumor
* Inflammatory joint disease

Primary outcomes:
measure: Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year
timeFrame: Post-op: 2-week, 6-month, 1-year, 2-year
measure: Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
timeFrame: Pre-op, Post-op (6 months, 1 year, and 2 years)
measure: Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
timeFrame: Pre-op, Post-op (6 months, 1 year, and 2 years)
measure: Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year
timeFrame: Pre-op, Post-op (6 months, 1 year, and 2 years)
measure: Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year
timeFrame: Pre-op, Post-op (6 months, 1 year, and 2 years)
Secondary outcomes:
measure: Stem subsidence
timeFrame: 1-year, 2-year
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
Study officials:
affiliation: Concordia Joint Replacement Group
name: Thomas Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: