Zero Degree Knee Positioner for Post-Knee Replacement Recovery

Overseen By Paisley Myers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Midlands

Disqualifiers: Knee replacement, Rheumatoid arthritis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a device called the Zero Degree Knee positioner aids recovery after knee replacement surgery. Researchers will compare patients' knee movement and recovery satisfaction with and without the device. Suitable candidates for this trial include those planning knee replacement due to osteoarthritis and who can walk independently before surgery. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery experiences for future knee replacement patients.

Do I need to stop my current medications for this 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.

What prior data suggests that the Zero Degree Knee Positioner is safe for post-knee replacement recovery?

Research has shown that similar devices to the Zero Degree Knee Positioner have raised safety concerns, such as bone loss and issues with immobile knee spacers. However, specific safety information about the Zero Degree Knee Positioner itself is not available. This study is labeled as "Not Applicable" for phase, indicating limited evidence on how well people tolerate the Zero Degree Knee Positioner. Discuss any concerns about joining a trial with this device with the study team or your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zero Degree Knee Positioner because it offers a new method for enhancing recovery after knee replacement surgery. Unlike traditional rehabilitation techniques, which often rely on exercises and physical therapy alone, this device positions the knee at zero degrees, potentially optimizing healing and reducing stiffness. By focusing on precise knee alignment, the Zero Degree Knee Positioner could accelerate recovery times and improve overall outcomes, providing a promising alternative to standard post-operative care.

What evidence suggests that the Zero Degree Knee positioner is effective for post-knee replacement recovery?

Research shows that keeping the leg straight after knee replacement surgery can reduce blood loss and improve knee mobility. In this trial, participants in one arm will use the Zero Degree Knee Positioner (ZDK), a tool designed to keep the leg straight and stable post-surgery. Studies have found that the ZDK can improve leg straightening in the early recovery stages, potentially enhancing recovery outlook. While more research is needed, these early results are promising for those considering the ZDK after knee replacement. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for men and women aged 40-80 who are about to have knee replacement surgery due to mild to advanced osteoarthritis. They must be able to walk on their own before the surgery. People who don't speak English, are pregnant, have had a previous knee replacement in the same leg, or have other conditions affecting their joints or gait can't join.

Inclusion Criteria

I am between 40 and 80 years old.

I am a candidate for a total knee replacement surgery.

I have been diagnosed with osteoarthritis, from mild to advanced.

Exclusion Criteria

Prisoners

Pregnant women

I have had a knee replacement in the same leg that needs surgery now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty and are randomized to receive either the Zero Degree Knee device or standard rehabilitation instructions

2 weeks

1 visit (in-person) at 2 weeks post-op

Rehabilitation

Participants follow either the Zero Degree Knee protocol or standard rehabilitation instructions, with measurements taken at 2 weeks, 4 weeks, and 3 months post-op

3 months

3 visits (in-person or virtual) at 2 weeks, 4 weeks, and 3 months post-op

Follow-up

Participants are monitored for safety and effectiveness after treatment, with patient-reported outcomes collected

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Zero Degree Knee Positioner

Trial Overview The study tests if using the Zero Degree Knee positioner after knee replacement surgery helps patients straighten their leg and improve walking sooner than usual care. Participants will either use this device at home following surgery or receive standard rehab instructions.

How Is the Trial Designed?

Group I: Zero Degree Knee Experimental Treatment 1 Intervention

Patients will receive the Zero Degree Knee device and instructions for use following total knee replacement.

Group II: Standard of Care Active Control 1 Intervention

Patients will receive standard of care instructions rehabilitation instructions following total knee replacement.

Who Is Running the Clinical Trial?

Prisma Health-Midlands

Lead Sponsor

Trials

24

Recruited

2,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05678231

Zero Degree Knee Positioner for Improved Earley ... The purpose of this study is to prospectively evaluate early post-operative knee extension and self-reported outcomes in patients using the Zero Degree Knee ...

2. withpower.com withpower.com/trial/phase-osteoarthritis-2023-c16ca

Zero Degree Knee Positioner for Post-Knee Replacement ... The research suggests that maintaining a consistent limb position can help reduce blood loss and improve the range of motion after knee replacement surgery, ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT05678231

Zero Degree Knee Positioner for Improved Earley Knee ... The purpose of this study is to prospectively evaluate early post-operative knee extension and self-reported outcomes in patients using the Zero Degree Knee ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2802824/

Early Postoperative Measures Predict 1- and 2-Year ... The aim of this study was to discern which early postoperative functional measures could predict functional ability at 1 year and 2 years after surgery.

5. clinicaltrial.be clinicaltrial.be/nl/details/188060?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Zero Degree Knee Positioner for Improved Earley ... Use of the Disposable Zero Degree Knee Postoperative Positioner for Improved Early Knee Extension and Self-Reported Outcomes Following Total Knee Arthroplasty.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10471706/

The role of a cryocompression device following total knee ... The study sought to investigate the effectiveness of a cryocompression Game Ready™ (GR) versus usual care protocol (UC) on early post-operative ...