๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-01-20

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty (NCT04814082)

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: LifeBridge Health

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.

Who can join: Review the eligibility criteria below.

Location: Sinai Hospital of Baltimore โ€” Baltimore, Maryland

Age range: 18 Years to 75 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Sinai Hospital of Baltimore โ€” Baltimore, Maryland

๐Ÿ“ž Contact the Study Coordinator

Phone: (410) 601-9467

Email: mgesheff@lifebridgehealth.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—