M-Vizion™ for Hip Revision Surgery

Recruiting at 8 trial locations

Overseen By Emily Hord, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medacta USA

Disqualifiers: Neuromuscular deficiency, Bone deterioration, Infection, others

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

Compensation: Varies

Number of Visits: 2

Duration: Surgery and immediate recovery

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new hip replacement part, the M-Vizion femoral component, for individuals requiring revision hip surgery. Researchers aim to understand how the new part integrates into the leg bone over time. The trial targets those needing a second hip replacement (revision hip arthroplasty) and will receive the M-Vizion component. Participants should not have conditions affecting their bones or nerves, as these could interfere with the study results. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to its potential availability.

Do I need to stop my current medications for the trial?

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that revision hip replacement surgery is generally safe for patients. Studies have found no serious side effects, except in a few rare cases. For example, one study found that the implant remained effective for 97.7% of patients two years after surgery, indicating that most did not require another surgery during this period.

Another study demonstrated significant improvement in patients' well-being after surgery. They experienced a transition from severe problems before surgery to enhanced mobility and ease in daily activities afterward.

Overall, the safety data suggest that revision hip replacement surgery is well-tolerated. However, like any surgery, it carries some risks, so discussing these with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The M-Vizion™ Macroscopic Radiographic Study is innovative because it focuses on enhancing the precision of imaging techniques used in revision hip arthroplasty. Traditional treatments rely heavily on standard X-rays and MRIs to evaluate the condition of the joint, which can sometimes miss subtle details. M-Vizion™ aims to improve the clarity and detail of pre- and post-operative imaging, potentially leading to better surgical outcomes and faster recovery times. Researchers are excited because this could mean more personalized treatment plans and fewer complications, ultimately improving the quality of life for patients undergoing revision hip surgeries.

What evidence suggests that revision hip arthroplasty is effective for subsidence after surgery?

Research has shown that revision hip replacement surgery can be effective, with 83.2% of these new hip joints functioning well after 10 years. This indicates success for most patients over a decade. However, about 21.3% of these initial replacements may require another surgery within 15 years. Patients typically experience improved movement and reduced pain following this surgery. Overall, revision hip replacement is a reliable option for those needing another hip surgery, aiming to enhance movement and alleviate pain. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects undergoing revision THA who will receive an M-Vizion femoral component according to the indications for use.

Male and female patients ages 21 - 80 years of age at the time of surgery.

Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision hip arthroplasty with the Medacta M-Vizion™ modular hip stem

Surgery and immediate recovery

Follow-up

Participants are monitored for subsidence of the hip stem

2 years

Regular follow-up visits, including a 2-year post-op visit

What Are the Treatments Tested in This Trial?

Interventions

• Revision Hip Arthroplasty

Who Is Running the Clinical Trial?

Medacta USA

Lead Sponsor

Trials

17

Recruited

2,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6613453/

Systematic review of the clinical effectiveness for long-term ... Long-term follow-up of THA was historically recommended to identify aseptically failing THA, minimising the risks associated with extensive changes.

2. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(22)00097-2/fulltext

How long do revised and multiply revised hip replacements ... After revision of primary total hip replacement, 21·3% (95% CI 18·6–24·4) of first revisions were revised again within 15 years, 22·3% (20·3–24·4) of second ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X23001285

Clinical and functional outcomes of revision hip ... The aim of this study is to present the clinical and functional outcomes of patients admitted for revision hip replacement surgeries at a tertiary care ...

4. archivesofmedicalscience.com archivesofmedicalscience.com/Comparison-of-clinical-characteristics-and-10-year-survival-rates-of-revision-hip,105492,0,2.html

Comparison of clinical characteristics and 10-year survival ... The overall 10-year survival rate of revision hip arthroplasty was 83.2%, and it was highest for the very early revisions (< 2 years).

5. aaos-annualmeeting-presskit.org aaos-annualmeeting-presskit.org/2023/research-news/total-hip-arthroplasty-patients-under-65-have-low-revision-rates-at-eight-years/

Total Hip Arthroplasty Patients Under 65 Have Low Revision ... Only 1% of sampled patients needed revision surgery for THA within an eight-year period. The study also highlighted higher THA revision rates among Black ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40519409/

Safety and Functional Outcomes Following Total Hip ... No serious adverse events were observed apart from the isolated revision case. At two years, implant survivorship was 97.7%, with a single ...

7. cureus.com cureus.com/articles/360420-safety-and-functional-outcomes-following-total-hip-arthroplasty-using-the-latitud-total-hip-replacement-system-in-patients-with-hip-fracture

Safety and Functional Outcomes Following Total Hip ... No serious adverse events were observed apart from the isolated revision case. At two years, implant survivorship was 97.7%, with a single ...

8. sicot-j.org sicot-j.org/articles/sicotj/full_html/2025/01/sicotj240145/sicotj240145.html

Safety and outcomes of bikini-incision DAA for hip ... The primary indication was osteoarthritis (88.4%). The mean preoperative HHS was 41.8, which significantly improved to 92.6 postoperatively (p < ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0883540325004759

10-Year Clinical Review of Revision Hip Arthroplasty ... Patient-reported outcome scores were available for 53 hips. The mean OHS in our overall cohort was 37.4 (SD 8.9). Patients who underwent more than one revision ...