Status:
UNKNOWN
Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
Lead Sponsor:
Regentis Biomaterials
Conditions:
Articular Cartilage Defects in the Knee Joint
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (mi...
Eligibility Criteria
Inclusion
- Main
- Age between 18 and 50.
- Single contained symptomatic lesion located on the femoral condyle of the femur graded as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.
- Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
- BMI ≤35
- Contralateral knee is asymptomatic, stable, fully functional and not medically treated.
- Main
Exclusion
- Presence of an additional grade III or IV symptomatic lesion.
- Recent Osteochondritis Dissecans within 1 year of baseline visit.
- Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.
- Patient is excluded if presenting untreated current meniscal tear or if previous menisci resection was within the last 6 months.
- Previous tendon repair or ligament reconstruction within the last 6 months.
- Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.
- Microfracture performed less than 1 year before baseline visit.
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT03262909
Start Date
November 14 2017
End Date
November 1 2024
Last Update
March 22 2022
Active Locations (13)
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1
Horizon Clinical Research
La Mesa, California, United States, 91942
2
Hoag Orthopedics
Orange, California, United States, 92868
3
University of Colorado
Denver, Colorado, United States, 80222
4
Shrock Clinical Research
Fort Lauderdale, Florida, United States, 33316