Partial Knee Replacement for Osteoarthritis

Overseen By JIS Research Institute

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: JIS Research Institute

Must not be taking: Immunosuppressives, Steroids

Disqualifiers: Rheumatoid arthritis, Osteoporosis, Cancer, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of partial knee replacements for individuals with severe knee arthritis. It compares a knee replacement attached with bone cement to one that does not use cement. The goal is to determine if the cementless option performs as well as the cemented one. Candidates may qualify if they have severe osteoarthritis in the knee, require surgery for pain relief or improved knee function, and have not undergone a knee replacement or significant knee surgery before.

As an unphased trial, this study provides an opportunity to contribute to advancements in knee replacement options and potentially benefit from innovative treatment.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressive drugs or have received steroid treatments recently, you may not be eligible to participate.

What prior data suggests that the Engage Partial Knee System is safe for osteoarthritis?

Research has shown that both cemented and cementless Engage Partial Knee systems are safe. Studies have found that cemented knee replacements usually have few complications and often improve knee function, performing well over the long term. Most patients experience positive outcomes with them.

Cementless knee systems have also demonstrated good results. Research suggests these systems might have a lower chance of requiring another surgery after ten years compared to cemented ones, indicating their safety and effectiveness.

Both types of knee systems are considered safe in the short term, with no major differences between them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Engage Partial Knee treatments because they offer two innovative approaches for knee replacement in osteoarthritis patients. The Cemented Engage Partial Knee uses bone cement for secure fixation, potentially offering enhanced stability and longevity compared to traditional methods. On the other hand, the Cementless Engage Partial Knee provides a cutting-edge option that eliminates the need for cement, allowing for natural bone growth and integration, which could lead to quicker recovery times and fewer complications. These advancements could significantly improve outcomes for patients suffering from knee osteoarthritis.

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

This trial will compare two treatment options for knee osteoarthritis: the Cemented Engage Partial Knee and the Cementless Engage Partial Knee. Research has shown that both systems are promising. Participants in the cemented arm may experience a 97% chance of the replacement lasting 10 years without needing replacement. Meanwhile, studies indicate that participants in the cementless arm have a 24% lower chance of needing another surgery compared to those in the cemented arm. Both types help people move and perform daily activities well over the long term. Overall, both treatments appear effective for managing knee osteoarthritis. ^{1 4 6 7 8}

Who Is on the Research Team?

David A Crawford, MD

Principal Investigator

JIS Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 21 with severe knee osteoarthritis or avascular necrosis limited to one part of the knee, who haven't found relief through other treatments and have a BMI under 40. They must be able to follow post-op care and return for check-ups. Excluded are those with certain diseases, previous knee surgeries that failed, allergies to metal or cement, pregnant women, drug abusers, heavy smokers, or anyone unlikely to complete the study.

Inclusion Criteria

Patients with BMI < 40

Patients who are able to follow post operative care instructions

I am having knee replacement surgery on one or both knees.

Exclusion Criteria

Participation in an interventional clinical research study procedure, other than a bilateral knee arthroplasty in this study, within the past 12 months

Prisoners or, individuals who are known to be abusing drugs or alcohol or are mentally incompetent

I have had both of my knees partially replaced, either at the same time or in stages.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo unicompartmental knee arthroplasty with either cemented or cementless fixation

6 weeks

1 visit (surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain score, implant survivorship, range of motion, and KOOS JR score

24 months

6 visits (in-person) at 6 weeks; 3, 6, 9, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Engage Partial Knee

Trial Overview The study compares two types of partial knee replacements: one using a cementless Engage Partial Knee System versus another using a cemented version. The goal is to see if the new cementless method works just as well as the traditional cemented approach in relieving pain and improving function.

How Is the Trial Designed?

Group I: Cemented Engage Partial Knee Active Control 1 Intervention

Engage partial knee implanted with bone cement for fixation.

Group II: Cementless Engage Partial Knee Active Control 1 Intervention

Engage partial knee implanted with cementless fixation.

Who Is Running the Clinical Trial?

JIS Research Institute

Lead Sponsor

Trials

1

Recruited

110+

Smith & Nephew, Inc.

Industry Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8513310/

Long-term effects of cemented and cementless fixations ... Long-term follow-up verified that cementless and cemented fixation have similar prosthesis survival rates, clinical scores and mobility.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424001871

Cemented versus cementless unicompartmental knee ... These findings showed a 97% survival at 10-years (95% CI: 92–100%), with 25 knees requiring revision. Based on the aforementioned data, it can be inferred that ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(19)31281-4/fulltext

5-year outcomes of a randomised controlled trial During 5 years of follow-up in the TOPKAT trial, PKR was found to be more effective but also less costly than TKR. Lower costs with PKR were a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05616884

Cemented vs. Cementless Unicompartmental Knee ... The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial ...

5. arthroplasty.biomedcentral.com arthroplasty.biomedcentral.com/articles/10.1186/s42836-024-00242-6

Unicompartmental knee replacement: controversies and ... Comparison of the 10-year outcomes of cemented and cementless unicompartmental knee replacements: data from the National Joint Registry for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9608915/

Patient-reported outcomes following cemented versus ... Patients who underwent cemented TKA had a statistically significant greater improvement in knee function scores (KOOS-Jr.) than did those having a cementless ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11064323/

Unicompartmental knee replacement: controversies and ... UKR is associated with superior patient-reported clinical and functional outcomes, as well as shorter hospital stays, fewer postoperative complications.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124000451

Cemented vs Cementless Robotic-Assisted Total Knee ... We reported no differences in any other short-term outcomes between the cementless and cemented Ra-TKA. Our data support efficacy and safety of cementless Ra- ...