Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects (SAGE)

• ClinicalTrials.gov Identifier: NCT03262909
• Recruitment Status: Active, not recruiting
• First Posted: August 25, 2017
• Last Update Posted: March 22, 2022
• Sponsor: Regentis Biomaterials
• Information provided by (Responsible Party): Regentis Biomaterials

Tracking Information

• First Submitted Date: August 17, 2017
• First Posted Date: August 25, 2017
• Last Update Posted Date: March 22, 2022
• Actual Study Start Date: November 14, 2017
• Estimated Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2017)

• 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
• Official Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Articular Cartilage Defects in the Knee Joint

Intervention

• Device: GelrinC
  Patients will undergo GelrinC implantation.
• Other: Microfracture historical control arm
  Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.

Study Arms

• Experimental: GelrinC prospective treatment arm
  Patients will undergo GelrinC implantation.
  Intervention: Device: GelrinC
• Microfracture historical control arm
  Microfracture historical control arm
  Intervention: Other: Microfracture historical control arm

Publications *

• Trattnig S, Ohel K, Mlynarik V, Juras V, Zbyn S, Korner A. Morphological and compositional monitoring of a new cell-free cartilage repair hydrogel technology - GelrinC by MR using semi-quantitative MOCART scoring and quantitative T2 index and new zonal T2 index calculation. Osteoarthritis Cartilage. 2015 Dec;23(12):2224-2232. doi: 10.1016/j.joca.2015.07.007. Epub 2015 Jul 14.
• Berdichevski A, Shachaf Y, Wechsler R, Seliktar D. Protein composition alters in vivo resorption of PEG-based hydrogels as monitored by contrast-enhanced MRI. Biomaterials. 2015 Feb;42:1-10. doi: 10.1016/j.biomaterials.2014.11.015. Epub 2014 Dec 9.
• Shah SS, Lee S, Mithoefer K. Next-Generation Marrow Stimulation Technology for Cartilage Repair: Basic Science to Clinical Application. JBJS Rev. 2021 Jan 19;9(1):e20.00090. doi: 10.2106/JBJS.RVW.20.00090. Review.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 23, 2017): 181
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Main Inclusion Criteria:

• 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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03262909
• Other Study ID Numbers: CLN-GR-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Regentis Biomaterials
• Original Responsible Party: Same as current
• Current Study Sponsor: Regentis Biomaterials
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Regentis Biomaterials
• Verification Date: March 2022