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NOT YET RECRUITING
NCT07908342
NA

Application of Perinatal Derivatives in Total Knee Arthroplasty

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

View on ClinicalTrials.gov

Summary

This pilot study investigators whether the use of perinatal derivatives during knee replacement, in the form of an injection around the joint and patch over the knee joint incision, improves patient outcomes (including survey-based measures, functional outcomes and wound healing). Perinatal derivatives are materials derived from donor placental tissue, including amnion, chorion and umbilical cord. The perinatal derivatives used in this study do not contain living cells. Forty-eight patients aged 40 to 75 years undergoing knee replacement will be enrolled in this study and randomized to either receive or not receive perinatal derivatives during knee replacement. Participants will follow-up in clinic at Week 2, Week 6 and Month 3 after surgery. An additional remote visit will be conducted at Year 1 after surgery. Outcomes that will be assessed include the visual analogue scale (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS) and wound healing (using a standard wound healing assessment).

Official title: Application of Perinatal Derivatives in Total Knee Arthroplasty: A Pilot Study

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-12

Completion Date

2028-12

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Intraoperative application of CTM Flow and CTM Thick

Perinatal derivative connective tissue allograft

PROCEDURE

Total knee arthroplasty (TKA)

Standard of care total knee arthroplasty (TKA)