Last updated: April 24, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting
Phase
N/A
Condition
Knee Injuries
Osteoarthritis
Treatment
Arthroscopic debridement with stem cell transplantation
Arthroscopic debridement only
Clinical Study ID
NCT03014401
19-2893
Ages 35-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age between 35 and 70 years-old
- Patient is scheduled to undergo one or a combination of the following procedures:
- Meniscal debridement or partial menisectomy
- Meniscal repair that does not necessitate a different postoperative protocol frommeniscal debridement or partial menisectomy
- Removal of loose bodies
- Chondroplasty
- Synovectomy
- Soft tissue releases for flexion or extension contracture.
- Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateralfemoral condyle (Kellgren-Lawrence Grade 2 or 3)
- < 6 months of knee pain or < 6 months of a significant exacerbation of existing kneepain
- Physical examination findings consistent with the proposed surgical procedure.
- Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapyand trial of anti-inflammatory medications, with or without concomitant bracing and/orinjections
Exclusion
Exclusion Criteria:
- Age < 35 or > 70 years old
- Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
- Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
- Patient scheduled to undergo any concomitant surgical procedures with the exceptionof:
- Meniscal debridement or partial menisectomy
- Meniscal repair that does not necessitate a different postoperative protocol frommeniscal debridement or partial menisectomy
- Removal of loose bodies
- Chondroplasty
- Synovectomy
- Soft tissue releases for flexion or extension contracture
- Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture,Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
- Previous arthroscopy within 1 year
- Subchondral edema
Study Design
Total Participants: 29
Treatment Group(s): 2
Primary Treatment: Arthroscopic debridement with stem cell transplantation
Phase:
Study Start date:
May 01, 2016
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Kerlan Jobe Orthopedic Institute
Santa Monica, California 90404
United StatesActive - Recruiting
Stanford University
Stanford, California 94305
United StatesSite Not Available
UC Health Steadman Hawkins Clinic - Denver Inverness
Denver, Colorado 80112
United StatesActive - Recruiting

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