Evaluation of the Agili-C Biphasic Implant in the Knee Joint

NCT01471236 | Completed

• 1 other identifier: CLN0002
• Study Type: interventional
• Target: 65
• Locations: 8 countries
• Sites: 9

Brief Summary

The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.

Conditions

Cartilage Diseases; Osteochondritis Dissecans

Keywords

cartilage; bone

Outcome Measures

Primary Outcomes (1)

• improvement in KOOS pain subscales

  The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale

  24 months

Secondary Outcomes (1)

• KOOS total score

  24 months

Other Outcomes (1)

• number of SAE

  24 months

Study Arms (1)

Agili-c bi-phasic implant

EXPERIMENTAL

mini-arthrotomy

Device: Agili-C Bi-phasic Implant; Procedure: mini-arthrotomy

Interventions

Agili-C Bi-phasic Implant DEVICE

The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone). The implant will be inserted gently in a pressed fit manner.

Also known as: Agili-C implant

Agili-c bi-phasic implant

mini-arthrotomy PROCEDURE

The procedure will be conducted according to hospital practice. The implants will be positioned via open incision, depending on lesion location, and Investigator's final decision. Related treatments during the procedure should be recorded. Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded.

Agili-c bi-phasic implant

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 55 years
• Symptomatic, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral isolated lesion of the femoral condyle, trochlea or the tibial plateau
• Defect area is less than 2 cm² after debridement. The defect is completely surrounded on all sides by healthy cartilage.
• Osteochondral defect ICRS Cartilage defect description type 1, 2, 3, 4A. Maximal defect depth should be up to 3 millimeters.
• Primary or secondary articular cartilage repair.
• Knee is stable or can be stabilized as a concomitant procedure.
• Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
• Signed informed consent.
• Any misalignments should be fully corrected at the end of the operative procedure.

You may not qualify if:

• Uncorrected axial misalignments \>5° that cannot be corrected.
• Patellar cartilage defects or pathology.
• Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair.
• Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present.
• Active acute or chronic infection of the treated knee.
• Inflammatory arthropathy or crystal-deposition arthropathy.
• Systemic cartilage and/or bone disorder; This implants integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone.
• Bony defect depth over 3 millimeters.
• Body mass index \>35.
• Asymptomatic articular cartilage defects.
• Bipolar articular cartilage defects.
• Osteoarthritis of the operated knee.
• Oral medications such as systemic corticosteroid therapy taken less than one year prior to surgery or chemotherapy.
• Previous operative treatment of Arthroscopic marrow stimulation technique or cell therapy operated within the last 6 months
• Any previous operation of cartilage treatment within the last 6 months

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (9)

Clinical Hospital ''Sveti Duh''

Zagreb, Croatia

Location

Fakultní nemocnice Brno

Brno, Czechia

Location

Uzsoki Street Hospital

Budapest, Hungary

Location

Rizzoli Orthopaedic Institute

Bologna, Italy

Location

Avimed Hospital

Katowice, Poland

Location

County Hospital of Timisoara,

Timișoara, Romania

Location

Institut Za Ortopediju "Banjica"

Belgrade, Serbia

Location

Clinical center of Vojvodina

Novi Sad, Serbia

Location

University Medical Centre, Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Cartilage Diseases; Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Osteochondritis; Bone Diseases

Study Officials

• Elizaveta Kon, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 15, 2011
• Study Start: June 1, 2011
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: March 6, 2025

Record last verified: 2020-02

Locations

IT (1); SL (1); CR (1); SE (2); PL (1); RO (1); CZ (1); HU (1)