Hip Implant for Hip Replacement

Recruiting at 9 trial locations

Overseen By Ryan Boylan, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Infection, Osteoporosis, Metabolic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

202 Participants Needed

Trial Summary

What is the purpose of this trial?

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment G7 Freedom Constrained Vivacit-E Liners for hip replacement?

The Biomet Freedom constrained liner, similar to the G7 Freedom Constrained Vivacit-E Liners, has been shown to help prevent hip dislocation in patients at high risk, with a study indicating its use in revision surgeries for recurrent dislocation. ^{1 2 3 4 5}

Is the hip implant generally safe for humans?

Some studies have reported issues with the safety of hip implants, such as early fractures and unique failure mechanisms, especially in certain conditions. However, there is also evidence that some liners, like the Vivacit-E, show no significant wear in specific tests, indicating mixed safety results. ^{2 3 6 7 8}

How does the G7 Freedom Constrained Vivacit-E Liner treatment differ from other hip replacement treatments?

The G7 Freedom Constrained Vivacit-E Liner is unique because it is designed to prevent dislocation in hip replacements by providing extra stability, which is particularly useful for patients at high risk of dislocation. This liner uses a special material infused with vitamin E to enhance durability, although there have been reports of early fractures in similar materials. ^{3 4 6 9 10}

Research Team

Hillary Overholser

Principal Investigator

Zimmer Biomet

Eligibility Criteria

This trial is for adults aged 18-80 with joint diseases like osteoarthritis or avascular necrosis, rheumatoid arthritis, high risk of hip dislocation, or those needing revision hip surgery. It's also for patients with certain types of hip fractures that can't be treated by other methods. Participants must be able to follow the study plan and give informed consent.

Inclusion Criteria

My bones have stopped growing.

I am between 18 and 80 years old.

Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; High risk for dislocation; Undergoing revision hip arthroplasty; Correction of functional deformity; In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent; Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent

Exclusion Criteria

I had or will have hip replacement surgery on the opposite side within 3 months.

My X-rays show fast joint damage or significant bone loss.

I have poor blood flow, muscle loss, or nerve disease at the surgery site.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty

Varies

Follow-up

Participants are monitored for safety, performance, and clinical benefits, including radiographic evaluations and patient-reported outcomes

10 years

Treatment Details

Interventions

• G7 Freedom Constrained Vivacit-E Liners

Trial Overview The trial is testing G7 Freedom Constrained Vivacit-E Liners in total hip replacements to see if they're safe and effective over the long term. This includes both first-time surgeries and revisions (re-doing previous surgeries).

Participant Groups

Group I: Total Hip Arthroplasty Treatment Group Experimental Treatment 1 Intervention

This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

References

1. Germany pubmed.ncbi.nlm.nih.gov

Constrained components for the unstable hip following total hip arthroplasty: a literature review. [2018]

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

Survivorship and Clinical Outcomes of Constrained Acetabular Liners in Primary and Revision Total Hip Arthroplasty: A Systematic Review. [2021]

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

New Failure Mechanism of Acetabular Constrained Liner: A Case Report. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Freedom Constrained Liner for the Treatment and Prevention of Dislocation in Total Hip Arthroplasty. [2022]

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

Closed Reduction of a Dislocated Constrained Total Hip Arthroplasty With 2-year Follow-up: A Case Report. [2023]

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

Early Fracture of a Vitamin-E-Infused, Highly Cross-Linked Polyethylene Liner After Total Hip Arthroplasty: A Case Report. [2021]

7. Sweden pubmed.ncbi.nlm.nih.gov

Performance of thin Vivacit-E hip liners: no relevant wear during ex vivo testing at high acetabular inclination angle. [2023]

8. Sweden pubmed.ncbi.nlm.nih.gov

Implant survival of 662 dual-mobility cups and 727 constrained liners in primary THA: small femoral head size increases the cumulative incidence of revision. [2021]

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

Closed reduction of a dislocation of a constrained acetabular component. [2004]

10. Belgium pubmed.ncbi.nlm.nih.gov

Failure mechanism of a constrained liner: a case report. [2012]