A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Regentis Biomaterials
- Enrollment
- 181
- Locations
- 13
- Primary Endpoint
- The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Study Overview
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 (microfracture) in the treatment of cartilage defects in the knee.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •Age between 18 and
- •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.
- •Contralateral knee is asymptomatic, stable, fully functional and not medically treated.
Exclusion Criteria
- •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.
Arms & Interventions
GelrinC prospective treatment arm
Patients will undergo GelrinC implantation.
Intervention: GelrinC (Device)
Microfracture historical control arm
Microfracture historical control arm
Intervention: Microfracture historical control arm (Other)
Outcomes
Primary Outcomes
The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Time Frame: 24 months post-surgery
The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Time Frame: 24 months post-surgery
Secondary Outcomes
No secondary outcomes reported