What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly post-operative rehabilitation methods like the Zero Degree Knee positioner, generally have minimal side effects. However, other common treatments such as NSAIDs can cause gastrointestinal issues, cardiovascular risks, and kidney problems. Corticosteroid injections may lead to joint infection, increased pain, and cartilage damage with repeated use. Physical therapy is generally safe but may cause temporary pain or discomfort. It is important to discuss these potential side effects with a healthcare provider to tailor the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for osteoarthritis, including NSAIDs like celecoxib, which are commonly used for pain management. Non-pharmacological treatments, such as the Zero Degree Knee positioner, focus on rehabilitation and improving knee function post-surgery. While specific FDA approvals for devices like the Zero Degree Knee positioner are not detailed, the emphasis on early rehabilitation and maintaining knee extension is consistent with current best practices in post-operative care for knee osteoarthritis.

What other types of research exist?

Promising novel alternatives to the Zero Degree Knee positioner for osteoarthritis patients include: 1) A pneumatic unloading knee brace with inflatable air bladders to alter knee mechanics and reduce pain, 2) Cognitive-behavioral group interventions to manage pain and improve function, 3) Mechanical traction at different knee angles to enhance physical function and range of motion, and 4) Triceps surae strength balancing to reduce knee loads and improve load symmetry.

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Zero Degree Knee Positioner for Post-Knee Replacement Recovery

N/A

Waitlist Available

Research Sponsored by Prisma Health-Midlands

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a non-invasive device used for rehabilitation rather than medication, side effects may include discomfort from using the positioner as directed during recovery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of the Zero Degree Knee device on post-operative knee extension in patients at 2 weeks post-op following total knee replacement as measured by lateral radiograph and physician interpretation.

Secondary study objectives

Effect of the Zero Degree Knee device on KOOS scores in patients undergoing total knee replacement surgery.

Effect of the Zero Degree Knee device on PROMIS Mobility scores in patients undergoing total knee replacement surgery.

Effect of the Zero Degree Knee device on PROMIS Pain Interference scores in patients undergoing total knee replacement surgery.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Zero Degree KneeExperimental Treatment1 Intervention

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

Group II: Standard of CareActive Control1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) aim to manage pain, improve function, and slow disease progression. Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Physical therapy and exercise, including interventions like the Zero Degree Knee positioner, enhance joint mobility and strength, promoting better recovery and function. Intraarticular glucocorticoid injections provide short-term pain relief by reducing local inflammation but are limited due to potential cartilage damage with repeated use. Emerging treatments like tissue gene therapy target cellular pathways to promote cartilage repair and reduce joint degradation. These treatments are crucial for OA patients as they help manage symptoms, improve quality of life, and potentially slow disease progression.

Effects of Wu Qin xi Qigong exercise on physical functioning in elderly people with knee osteoarthritis: A randomized controlled trial.