Robot-Assisted vs. Manual Knee Replacement for Osteoarthritis

No longer recruiting at 2 trial locations

Overseen By Lauren Cole

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Infections, Neurological disorders, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of knee replacement surgery for individuals with knee osteoarthritis. One method involves robotic assistance (Total Knee Robotically-Assisted), while the other relies on the surgeon performing the procedure manually. The trial aims to determine any differences in knee function following each type of surgery. It may suit those with osteoarthritis in one knee who are considering knee replacement surgery. As an unphased trial, it provides a unique opportunity to explore innovative surgical techniques that could improve recovery and knee function.

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 prior data suggests that robot-assisted knee replacement is safe for osteoarthritis patients?

Research shows that robot-assisted knee replacements are generally safe and may offer benefits over traditional methods. Studies have found that this robotic technique causes less damage to the soft tissues around the knee, which is important because less tissue damage often leads to a smoother recovery.

In one study, patients who underwent robotic knee surgery lost about 23.7% less blood compared to those who had manual surgery. Losing less blood can reduce the need for a blood transfusion. However, some areas of the knee experienced more cases of soft tissue injuries.

Overall, patients handle robot-assisted knee replacement well. These findings suggest that while some risks exist, the benefits could make recovery easier for many people. Discussing all options with a medical professional before deciding on surgery is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotically-assisted knee replacement because it offers a new level of precision and customization compared to traditional manual surgeries. Unlike standard procedures where the surgeon directly handles the instruments, this technique uses a dedicated surgical robot to assist in making precise bone cuts. The robot ensures that the surgery aligns perfectly with the planned surgical strategy, potentially leading to better outcomes, faster recovery, and improved joint function for patients with osteoarthritis.

What evidence suggests that robot-assisted knee replacement is effective for osteoarthritis?

This trial will compare robot-assisted knee replacements with manual knee replacements for osteoarthritis. Studies have shown that robots in total knee replacements can yield better results than traditional methods. Research indicates that this approach allows for more precise placement of knee implants, improving joint function and alignment. Patients have reported positive outcomes from robotic surgeries, with improvements observed over time. Although researchers continue to study the long-term benefits, early results suggest this method could enhance recovery and satisfaction. Overall, robot-assisted knee replacements offer promise for those with osteoarthritis requiring surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Matthew P Abdel

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals aged 20-100 with osteoarthritis needing a knee replacement and can consent to the study. It's not for those with severe knee deformities, inflammatory arthritis, previous infections or replacements in the knee, BMI over 40, substance abuse issues, certain communicable diseases or psychiatric conditions.

Inclusion Criteria

Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis

All eligible male or female patients between the ages of 20 years to 100 years old

All included study participants must be able to give an informed consent.

Exclusion Criteria

You have a condition that affects your ability to walk or bear weight normally.

You have had a knee replacement surgery in the past and have an artificial knee joint.

You have serious leg deformities caused by injuries, diseases like arthritis or bone infections, or other problems like dislocated kneecap.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robotically-assisted or manually-executed total knee arthroplasty

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Total Knee Robotically-Assisted

Trial Overview The study compares robot-assisted total knee arthroplasty (replacement) to the traditional manual method to see if there's a difference in how well patients do after surgery.

How Is the Trial Designed?

Group I: Total Knee Robotically-Assisted Experimental Treatment 1 Intervention

The intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.

Group II: Total Knee Manual-Executed by Surgeon Active Control 1 Intervention

Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9350694/

Clinical results and patient-reported outcomes following ... RA-TKA demonstrated consistent clinical results across multiple institutions with excellent PROMs that continued to improve over time.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2059775425005401

Robotic-assisted total knee arthroplasty leads to a higher ... Specifically, R-TKA has demonstrated enhanced consistency in radiological outcomes. However, consistent improvements in clinical results remains to be proven, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11978122/

Survivorship in robotic total knee arthroplasty compared ... At ten years postoperatively, pooled survivorship rates in the conventional group were 96.9% (95% CI: 95–98) and 97.8% (95% CI: 96.7–98.5) in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X24000572

Early results of robot-assisted knee replacement Primary total knee replacement has long proven its effectiveness in the treatment of osteoarthritis of the knee joint at stages 3–4. It is well known that this ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-05372-w

Comparison of the efficacy of robot-assisted total knee ... Compared with conventional TKA, the robot-assisted system achieved significantly better outcomes regarding prosthesis implantation accuracy and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11347482/

Comparison of the efficacy and safety of MAKO robot ... In terms of safety, MAKO robot-assisted TKA has been shown to reduce damage to the soft tissues around the knee joint [28]. Kayani et al. found ...

7. jbjs.org jbjs.org/reader.php?rsuite_id=7d84c9ab-a526-4468-b1b5-ccfae2cb05da

A Snapshot of the American Robotic Total Knee ... A small study compared 50 robotic TKA vs. 50 mTKA patients and found a 23.7% decrease in blood loss and relative risk of transfusion with rTKA ( ...

8. isakos.com isakos.com/GlobalLink/Abstract/7786

Soft Tissue Safety In Robotic-Assisted Total Knee ... Soft tissue injuries, particularly in the posterior compartment, were observed, with a 68.9% injury rate. Despite the increased damage from expanded margins, ...