Articular Cartilage Defects in the Knee JointSAGENCT03262909
Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
A study testing GelrinC in people with Articular Cartilage Defects in the Knee Joint, run by Regentis Biomaterials at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Articular Cartilage Defects in the Knee Joint
- What is being tested?
- GelrinC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 13 sitesUnited States
- Study dates
- 14 Nov 2017to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Tria Institute
Bloomington, Minnesota, 55431
Alpine Orthopedics
Bozeman, Montana, 59718
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
University of Colorado
Denver, Colorado, 80222
Shrock Clinical Research
Fort Lauderdale, Florida, 33316
Andrews Institute
Gulf Breeze, Florida, 32561
Horizon Clinical Research
La Mesa, California, 91942
Mansfield Orthopedics
Morrisville, Vermont, 05661
Hoag Orthopedics
Orange, California, 92868
Jewett Orthopaedic Clinic
Orlando, Florida, 32822
Peninsula Orthopaedic Associates
Salisbury, Maryland, 21804
Optim Orthopedics
Savannah, Georgia, 31405
About this study
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
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.
- Being tested
- GelrinC, Microfracture historical control arm
- Keywords
- cartilage damage, cartilage defect, chondral lesion, osteochondral lesion, femur, condyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelrinCDevice
Patients will undergo GelrinC implantation.
Microfracture historical control armOther
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
| Study group | Role | What they receive |
|---|---|---|
| GelrinC prospective treatment arm | Experimental | Patients will undergo GelrinC implantation. Receives: Device: GelrinC |
| Microfracture historical control arm | Other | Microfracture historical control arm Receives: Other: Microfracture historical control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Measured: 24 months post-surgery
The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Measured: 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start14 Nov 2017
- Primary completionApr 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Articular Cartilage Defects in the Knee JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regentis Biomaterials
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262909
- Sponsor's protocol ID
- CLN-GR-01
- Acronym
- SAGE
- Status last verified
- Mar 2022
- First submitted
- 17 Aug 2017
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 26187572Berdichevski 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.
PubMed 25542788Shah 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.
PubMed 33512974
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03262909
- Acronym / sponsor ID
- SAGE / CLN-GR-01
- Keywords
- cartilage damage, cartilage defect, chondral lesion, osteochondral lesion, femur, condyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Regentis BiomaterialsIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GelrinC prospective treatment arm | Experimental | Device: GelrinCPatients will undergo GelrinC implantation. |
| Microfracture historical control arm | Other | Other: Microfracture historical control armMicrofracture historical control arm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GelrinCPatients will undergo GelrinC implantation. | Device | GelrinC prospective treatment arm |
| Microfracture historical control armPatients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure. | Other | Microfracture historical control arm |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Background: PubMed 26187572Trattnig 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.
- Background: PubMed 25542788Berdichevski 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.
- Derived from this study: PubMed 33512974Shah 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GelrinC in people with Articular Cartilage Defects in the Knee Joint, run by Regentis Biomaterials at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262909, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.