Pinnacle RSA Study

DePuy Synthes

Status: Terminated

Conditions: Osteoarthritis; Degenerative Arthritis

Treatments: Device: THA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04070989

DSJ_2018_02

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

Posterior Approach

Experimental group

Description:

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

Treatment:

Device: THA

Lateral Approach

Experimental group

Description:

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

Treatment:

Device: THA

Anterior Approach

Experimental group

Description:

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

Treatment:

Device: THA