Hip Replacement Systems for Hip Osteoarthritis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two hip replacement systems, Pinnacle Dual Mobility and Pinnacle Gription, to assess their effectiveness for individuals with hip osteoarthritis. It follows earlier studies and aims to understand the effectiveness and safety of these systems for those who have undergone hip replacements. Participants from previous studies may be suitable candidates for this trial. This trial offers a chance to contribute to the improvement of hip replacement options and gain insights into these treatments. As an unphased trial, it provides a unique opportunity to contribute to ongoing research and potentially enhance future hip replacement options.

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 prior data suggests that these hip replacement systems are safe for hip osteoarthritis?

Research has shown that the Pinnacle Dual Mobility hip replacement system is generally safe. Studies indicate it has low rates of dislocation and other issues, suggesting good patient tolerance.

For the Pinnacle Gription Acetabular Cup, results are also positive. Research indicates that this cup remains securely in place after surgery. These studies reported no complications, suggesting it is safe for hip replacements.

Overall, both systems appear to be safe choices for those considering hip replacement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Pinnacle Dual Mobility and Pinnacle Gription Acetabular Cup systems because they offer innovative solutions for hip osteoarthritis. Unlike traditional hip replacement options, the Pinnacle Dual Mobility system provides enhanced stability and a lower risk of dislocation due to its unique dual mobility design, which allows for a greater range of motion. Meanwhile, the Pinnacle Gription Acetabular Cup features a special porous coating that improves the integration of the implant with the bone, potentially leading to better long-term outcomes. These advancements aim to improve patient mobility and reduce complications, making them promising options for those suffering from hip osteoarthritis.

What evidence suggests that this trial's treatments could be effective for hip osteoarthritis?

This trial will compare the Pinnacle Dual Mobility and Pinnacle Gription Acetabular Cup systems for hip replacements. Research has shown that both systems perform well for hip replacements. Studies indicate that dual-mobility systems like the Pinnacle Dual Mobility are safe, with a low risk of dislocation or complications, helping to maintain hip stability. For the Pinnacle Gription, evidence shows that 98% of patients do not require another surgery within five years, and this system also improves leg length after surgery, aiding in walking and balance. Both systems have demonstrated positive results for individuals with hip osteoarthritis. ^{1 2 3 4 5}

Who Is on the Research Team?

Thomas Turgeon, MD

Principal Investigator

Concordia Joint Replacement Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10907504/

Dual-Mobility Acetabular Components in Primary Total Hip ... This matched study shows that there is no difference in local complication rates between DM and conventional THA articulations.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05930067?term=AREA%5BBasicSearch%5D(pinnacle)&rank=1&checkSpell=

Continuation of Patient Follow-up to 2 Years for the ... The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty ...

3. withpower.com withpower.com/trial/phase-osteoarthritis-hip-4-2023-b5fa2

Hip Replacement Systems for Hip Osteoarthritis Studies show that dual-mobility systems, like the Pinnacle Dual Mobility, generally have good safety records with low rates of dislocation and complications.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05357664?term=pinnacle&rank=4&checkSpell=

Study Details | NCT05357664 | PINNACLE® DM RSA Study 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 ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/17453674.2020.1798658

Study protocol: Effectiveness of dual-mobility cups ... The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty ...