PINNACLE® DM RSA Study

NCT05357664 | Terminated Results FDA Device

• 1 other identifier: DSJ_2019_02
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct 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. Additionally, the data from this study will be compared to historical PINNACLE® data obtained in study DSJ\_2018\_02.

Conditions

Osteoarthritis; Degenerative Arthritis; Revision Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Superior Cup Migration

  Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)

  2 years

Secondary Outcomes (6)

• Harris Hip Score

  6 weeks post operative

• HOOS Jr Score

  6 weeks

• FJS-12

  6 weeks

• Linear Head Penetration

  6 weeks, 1 year, 2 years

• RSA Measured Subsidence (Superior Cup Migration)

  3 months, 6 months and 1 year

Study Arms (2)

Total Hip Arthroplasty

EXPERIMENTAL

Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses

Device: Total Hip Arthroplasty

Revision Total Hip Arthroplasty

EXPERIMENTAL

Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses

Device: Revision Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty DEVICE

Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses

Also known as: THA

Total Hip Arthroplasty

Revision Total Hip Arthroplasty DEVICE

Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses

Also known as: RTHA

Revision Total Hip Arthroplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals requiring primary THA for:
• a severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
• failed previous hip surgery.
• or dislocation risks.
• 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.
• Individuals who are willing and able to return for follow-up as specified by the study protocol.
• Individuals who are a minimum age of 21 years at the time of consent.
• Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol.

You may not qualify if:

• Individuals have active local or systemic infection.
• Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
• Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of bone fracture and/or the lack of adequate bone to support the implant(s).
• Individuals with Charcot's or Paget's disease.
• Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
• Women who are pregnant or lactating.
• 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 6 months following the time of consent into this study.
• Individuals that have amputations in either leg that would impact rehabilitation following surgery.
• Individuals who are bedridden per the Investigators determination
• Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
• Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
• Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia.
• Subject has a medical condition with less than 2 years life expectancy.
• Individual has a BMI \>45 kg/m2.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (3)

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

Winnipeg, Manitoba, Canada

Location

QEII Health Sciences Centre & Dalhousie University

Halifax, Nova Scotia, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

Study was terminated prior to subjects reaching three-month timepoint; therefore, only secondary endpoint data at six-weeks was collected. RSA evaluations are performed once all subjects have completed follow-up at a protocol prescribed timepoint. Since the study was terminated following the enrollment of eleven subjects, no RSA evaluations took place.

Results Point of Contact

• Title: Dave Whalen
• Organization: DePuy Synthes

dwhalen@its.jnj.com

574-404-9399

Study Officials

• Thomas Turgeon, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: October 6, 2022
• Primary Completion: December 20, 2022
• Study Completion: February 9, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (3)