Hip Replacement Systems for Hip Osteoarthritis

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Radiostereometric Analysis Network

Must not be taking: Muscular disorder medications

Disqualifiers: Infection, Osteoporosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

82 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.

What data supports the effectiveness of the Pinnacle Dual Mobility and Pinnacle Gription Acetabular Cup treatment for hip osteoarthritis?

The Pinnacle Acetabular Cup System has shown good survivorship in hip replacement surgeries over 5-10 years. Additionally, the Pinnacle Gription, an advanced version of the standard Pinnacle socket, has demonstrated positive early results in revision hip surgeries. Dual-mobility technology, similar to the Pinnacle Dual Mobility, has been effective in reducing dislocation risks in hip replacements. ^{1 2 3 4 5}

Is the Pinnacle Dual Mobility or Pinnacle Gription Acetabular Cup safe for hip replacement?

Studies show that dual-mobility systems, like the Pinnacle Dual Mobility, generally have good safety records with low rates of dislocation and complications. The Pinnacle Gription, introduced in 2007, also shows positive early results in revision hip surgeries, indicating it is generally safe for use in humans. ^{2 3 6 7 8}

What makes the Pinnacle Dual Mobility and Pinnacle Gription Acetabular Cup treatment unique for hip osteoarthritis?

The Pinnacle Dual Mobility system is unique because it uses a dual-mobility design, which includes a mobile polyethylene liner that helps prevent dislocation, a common issue in hip replacements. The Pinnacle Gription Acetabular Cup features a high-friction surface coating that enhances stability and integration with the bone, making it a novel option for hip osteoarthritis treatment. ^{2 3 4 9 10}

What is the purpose of this trial?

The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively).

Research Team

Thomas Turgeon, MD

Principal Investigator

Concordia Joint Replacement Group

Eligibility Criteria

This trial is for individuals previously enrolled in the DSJ_2018_02 and DSJ_2019_02 studies, without severe diseases like Charcot's or Paget's, not bedridden, with a life expectancy over 2 years, BMI under 45 kg/m2, no recent hip implants or participation in other trials. Pregnant women and those with infections or poor bone quality are excluded.

Inclusion Criteria

Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02

Exclusion Criteria

I have Charcot's or Paget's disease.

I currently have an infection.

I have not had, nor plan to have, hip surgery on the opposite side within 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total hip arthroplasty with Pinnacle Gription or Pinnacle Dual Mobility systems

6 weeks

Post-op visits at 6 weeks, 3 months, 6 months, 1 year, and 2 years

Follow-up

Participants are monitored for stability, pain, function, and complications using radiographic and patient-reported outcome measures

2 years

Regular follow-up visits at 6 weeks, 3 months, 6 months, 1 year, and 2 years

Treatment Details

Interventions

• Pinnacle Dual Mobility
• Pinnacle Gription Acetabular Cup

Trial Overview The study continues to evaluate two hip replacement systems: Pinnacle Dual Mobility and Pinnacle Gription Acetabular Cup. It follows up on patients' experiences from previous related trials to assess long-term outcomes of these devices.

Participant Groups

Group I: Pinnacle Gription Experimental Treatment 1 Intervention

Pinnacle Gription Acetabular Cup

Group II: Pinnacle Dual Mobility Experimental Treatment 1 Intervention

Pinnacle Dual Mobility System

Who Is Running the Clinical Trial?

Canadian Radiostereometric Analysis Network

Lead Sponsor

Trials

9

Recruited

420+

DePuy Synthes

Industry Sponsor

Trials

33

Recruited

4,900+

Findings from Research

The dual-mobility acetabular cup (DMC) significantly reduces the risk of revision surgery compared to conventional total hip arthroplasty (THA), with an adjusted hazard ratio of 0.75 based on a study of 4,520 hip fractures.

DMCs also show a notably lower risk of revision due to dislocation (AHR = 0.45), indicating improved stability, although there is a higher risk of death associated with DMC use (AHR = 1.49).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Revision Risk for Dual-Mobility Cup in Total Hip Replacement Due to Hip Fracture: A Matched-Pair Analysis of 9,040 Cases from the Nordic Arthroplasty Register Association (NARA). Jobory, A., Kärrholm, J., Overgaard, S., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Survivorship of a modular acetabular cup system: medium- to long-term follow-up. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Early results of a high friction surface coated uncemented socket in revision hip arthroplasty. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The dual-mobility POLARCUP: first results from a multicenter study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Absence of instabilities and intra-prosthetic dislocations at 7 to 11 years following THA using a fourth-generation cementless dual mobility acetabular cup. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Wear of dual-mobility cups: a review article. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Dual mobility cup in total hip arthroplasty. The experiense of the university hospital. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

The use of a dual-articulation acetabular cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 15 years. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Reduced Revision Risk for Dual-Mobility Cup in Total Hip Replacement Due to Hip Fracture: A Matched-Pair Analysis of 9,040 Cases from the Nordic Arthroplasty Register Association (NARA). [2020]

9. Italy pubmed.ncbi.nlm.nih.gov

Dual mobility acetabular component in revision total hip arthroplasty for persistent dislocation: no dislocations in 50 hips after 1-5 years. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Outcomes of dual-mobility acetabular cup for instability in primary and revision total hip arthroplasty. [2021]