Pinnacle RSA Study

NCT ID: NCT04070989

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2023-06-16

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.

Conditions

Osteoarthritis; Degenerative Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Posterior Approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach

Group Type: EXPERIMENTAL

THA

Intervention Type: DEVICE

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Lateral Approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach

Group Type: EXPERIMENTAL

THA

Intervention Type: DEVICE

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Anterior Approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach

Group Type: EXPERIMENTAL

THA

Intervention Type: DEVICE

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Interventions

THA

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba

Winnipeg, Manitoba, Canada

QEII Health Sciences Centre & Dalhousie University

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DSJ_2018_02

Identifier Type: -

Identifier Source: org_study_id