Zero Degree Knee Positioner for Improved Earley Knee Extension Following Total Knee Arthroplasty

NCT05678231 | Active Not Recruiting

• 1 other identifier: 1983229
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have demonstrated that early rehabilitation interventions following knee arthroplasty (TKA) can shorten the time needed to regain baseline extension/full extension and gait mechanics. As telehealth visits and home-based rehabilitation increases with advancements in technology, much of this rehabilitation is projected to be performed at home. 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 positioner (ZDK) compared to subjects not using the ZDK. Patients electing to undergo primary TKA will be recruited into the study and randomized to receive and follow the ZDK protocol post-operatively or standard of care rehabilitation instructions. Knee extension measurements will be recorded at 2 weeks post-op and patient-reported outcome measurements will be recorded pre-operatively and at various post-op timepoints.

Conditions

Osteoarthritis, Knee

Keywords

Knee arthroplasty; Osteoarthritis; Total knee replacement

Outcome Measures

Primary Outcomes (1)

• 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.

  The degree of knee extension at the 2 week post-operative visit will be measured via lateral radiograph interpreted by an orthopedic surgeon.

  2 weeks

Secondary Outcomes (4)

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

  3 months

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

  3 months

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

  3 months

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

  3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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

Zero Degree Knee

EXPERIMENTAL

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

Device: Zero Degree Knee Positioner

Interventions

Zero Degree Knee Positioner DEVICE

The Zero Degree Knee (ZDK) positioning device is a knee extension pillow designed to simplify knee extension exercise following TKA surgery.

Zero Degree Knee

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 40-80 years
• Candidate for total knee arthroplasty
• Diagnosis of mild to advanced osteoarthritis
• The ability to walk independently at baseline

You may not qualify if:

• History of knee replacement in operative limb (i.e. patients undergoing revision surgery)
• Neuromuscular/skeletal or connective tissue conditions that can alter gait or joint mechanics (joint infection, gout, rheumatoid arthritis)
• Pregnant women
• Prisoners
• Non-English speakers

Sponsors & Collaborators

• Prisma Health-Midlands: lead

Study Sites (1)

Prisma Health - Midlands

Columbia, South Carolina, 29203, United States

Location

Related Publications (5)

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 RESULT

• Fortier LM, Rockov ZA, Chen AF, Rajaee SS. Activity Recommendations After Total Hip and Total Knee Arthroplasty. J Bone Joint Surg Am. 2021 Mar 3;103(5):446-455. doi: 10.2106/JBJS.20.00983.

  PMID: 33337819 RESULT

• Su EP. Fixed flexion deformity and total knee arthroplasty. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):112-5. doi: 10.1302/0301-620X.94B11.30512.

  PMID: 23118396 RESULT

• Prvu Bettger J, Green CL, Holmes DN, Chokshi A, Mather RC 3rd, Hoch BT, de Leon AJ, Aluisio F, Seyler TM, Del Gaizo DJ, Chiavetta J, Webb L, Miller V, Smith JM, Peterson ED. Effects of Virtual Exercise Rehabilitation In-Home Therapy Compared with Traditional Care After Total Knee Arthroplasty: VERITAS, a Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Jan 15;102(2):101-109. doi: 10.2106/JBJS.19.00695.

  PMID: 31743238 RESULT

• Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD004260. doi: 10.1002/14651858.CD004260.pub3.

  PMID: 24500904 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients electing to undergo primary TKA will be recruited into the study and randomized to receive and follow the ZDK protocol post-operatively or standard of care rehabilitation instructions.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 10, 2023
• Study Start: February 10, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)