Clinical trial NCT04070989: Pinnacle RSA Study
Official title: Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Degenerative Arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. This will be summarized for each surgical approach separately, as well as combined.


Eligibility criteria: Inclusion Criteria:

1. Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck
2. Individuals who are able to speak, 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 to DePuy Synthes
3. Individuals who are willing and able to return for follow-up as specified by the study protocol
4. Individuals who are a minimum age of 21 years at the time of consent
5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol

Exclusion Criteria:

1. Individuals have active local or systemic infection
2. Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery
3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s)
4. Individuals with Charcot's or Paget's disease
5. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA
6. Women that are pregnant or lactating
7. Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the following 6 months at the time of consent into this study
8. Individuals that have amputations in either leg that would impact rehabilitation following surgery
9. Individuals who are bedridden.
10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months
11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims
12. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements
13. Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia
14. Subject has a medical condition with less than 2 years life expectancy
15. Individual has a BMI \>45 kg/m2.

Primary outcomes:
measure: Mean superior cup migration (subsidence) at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: RSA measured cup subsidence at 3 months
timeFrame: 3 months
measure: X-axis translation of acetabular shell at 3 months
timeFrame: 3 months
measure: Z-axis translation of acetabular shell at 3 months
timeFrame: 3 months
measure: X-axis rotation of the acetabular shell at 3 months
timeFrame: 3 months
measure: Y-axis rotation of the acetabular shell at 3 months
timeFrame: 3 months
measure: Z-axis rotation of the acetabular shell at 3 months
timeFrame: 3 months
measure: Maximal total point motion of the acetabular shell at 3 months
timeFrame: 3 months
measure: Harris Hip Score at 3 months
timeFrame: 3 months
measure: HOOS Jr. Score at 3 months
timeFrame: 3 months
measure: FJS-12 at 3 months
timeFrame: 3 months
measure: RSA measured cup subsidence at 6 months
timeFrame: 6 months
measure: X-axis translation of acetabular shell at 6 months
timeFrame: 6 months
measure: Z-axis translation of acetabular shell at 6 months
timeFrame: 6 months
measure: X-axis rotation of the acetabular shell at 6 months
timeFrame: 6 months
measure: Y-axis rotation of the acetabular shell at 6 months
timeFrame: 6 months
measure: Z-axis rotation of the acetabular shell at 6 months
timeFrame: 6 months
measure: Maximal total point motion of the acetabular shell at 6 months
timeFrame: 6 months
measure: Harris Hip Score at 6 months
timeFrame: 6 months
measure: HOOS Jr. Score at 6 months
timeFrame: 6 months
measure: FJS-12 at 6 months
timeFrame: 6 months
measure: RSA measured cup subsidence at 1 year
timeFrame: 1 year
measure: X-axis translation of acetabular shell at 1 year
timeFrame: 1 year
measure: Z-axis translation of acetabular shell at 1 year
timeFrame: 1 year
measure: X-axis rotation of the acetabular shell at 1 year
timeFrame: 1 year
measure: Y-axis rotation of the acetabular shell at 1 year
timeFrame: 1 year
measure: Z-axis rotation of the acetabular shell at 1 year
timeFrame: 1 year
measure: Maximal total point motion of the acetabular shell at 1 year
timeFrame: 1 year
measure: Harris Hip Score at 1 year
timeFrame: 1 year
measure: HOOS Jr. Score at 1 year
timeFrame: 1 year
measure: FJS-12 at 1 year
timeFrame: 1 year
measure: X-axis translation of acetabular shell at 2 years
timeFrame: 2 years
measure: Z-axis translation of acetabular shell at 2 years
timeFrame: 2 years
measure: X-axis rotation of the acetabular shell at 2 years
timeFrame: 2 years
measure: Y-axis rotation of the acetabular shell at 2 years
timeFrame: 2 years
measure: Z-axis rotation of the acetabular shell at 2 years
timeFrame: 2 years
measure: Maximal total point motion of the acetabular shell at 2 years
timeFrame: 2 years
measure: Harris Hip Score at 2 years
timeFrame: 2 years
measure: HOOS Jr. Score at 2 years
timeFrame: 2 years
measure: FJS-12 at 2 years
timeFrame: 2 years
measure: Linear head penetration at 1 year
timeFrame: 1 year
measure: Linear head penetration at 2 years
timeFrame: 2 years
Other outcomes:
measure: Correlation of functional and health status outcomes vs. RSA
timeFrame: 2 years
Locations:
city: Winnipeg
country: Canada
facility: Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Centre & Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: