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

154 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special pillow called the ZDK that helps people straighten their knee after knee replacement surgery. It uses gravity to gently stretch the knee, making it easier for patients to regain movement. The study focuses on patients who have had knee replacement surgery and often face stiffness in their knees.

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.

Is the Zero Degree Knee Positioner safe for use in humans?

The safety of static knee spacers, which may be similar to the Zero Degree Knee Positioner, has been questioned due to complications like bone loss, spacer migration, and fractures in challenging cases. However, this data is specific to severe conditions and may not directly apply to all uses of the Zero Degree Knee Positioner. ^{1 2 3 4 5}

How does the Zero Degree Knee Positioner treatment differ from other treatments for post-knee replacement recovery?

The Zero Degree Knee Positioner is unique because it focuses on maintaining a consistent limb position to potentially reduce blood loss and improve the range of motion after knee replacement surgery, which may offer an easier alternative to traditional rehabilitation methods that emphasize early exercise and ambulation. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Zero Degree Knee Positioner for post-knee replacement recovery?

The research suggests that maintaining a consistent limb position can help reduce blood loss and improve the range of motion after knee replacement surgery, which may support the use of the Zero Degree Knee Positioner for recovery. ^{6 7 10 11 12}

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. Germany pubmed.ncbi.nlm.nih.gov

Effect of different postoperative flexion regimes on the outcomes of total knee arthroplasty: randomized controlled trial. [2018]

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

Total knee arthroplasty: range of motion across five systems. [2019]

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

Improvements in knee range and symptomatic and functional behavior after knee arthroplasty based on preoperative restriction in range. [2012]

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

High-flexion total knee replacement: functional outcome at one year. [2021]

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

Rehabilitation program following polycentric total knee arthroplasty. [2019]

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

Static Non-articulating Knee Spacers Are Associated with a High Degree of Morbidity in Challenging Clinical Scenarios. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Application of an articulating spacer in two-stage revision for severe infection after total knee arthroplasty. [2021]

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

Columbus primary total knee replacement: a 2- to 4-year followup of the use of intraoperative navigation-derived data to predict pre and postoperative function. [2022]

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

Articulating vs. Static antibiotic impregnated spacers in revision total knee arthroplasty for sepsis. A systematic review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

High incidence of loosening of the femoral component in legacy posterior stabilised-flex total knee replacement. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

The mini-incision mid-vastus approach for total knee arthroplasty. [2021]

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

Biomechanical evaluation of degree of freedom of movements of a novel high-flexion knee for its suitability in eastern lifestyles. [2019]