Safety and Efficacy Study of HYTOP® in the Treatment of Focal Chondral Defects.

NCT01791062 | Completed

• 1 other identifier: CAREKT-DE-2011-12
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The two-layer bioresorbable HYTOP® matrix consists of an upper layer of highly purified porcine splint-skin which contains natural pores, and a lower layer of highly purified collagen fleece containing hyaluronan (HA). In this study, the medical device will be used and evaluated in a one-step procedure combining microfracturing with surgical implantation of HYTOP®. HYTOP® will support haemostasis in the articular cartilage defect, act as a support for cell growth and as a three-dimensional scaffold for cell differentiation. HYTOP® will protect the underlying tissue after cartilage debridement and/or microfracturing of the subchondral bone. The primary working hypothesis is that HYTOP® is safe and suitable as a cell-free matrix to support haemostasis, as a cover for the cartilage lesion and eventually to enhance cartilage regeneration in a one-step surgical procedure.

Conditions

Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint

Keywords

cartilage tissue engineering; hyaluronan; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Number of adverse events with causal relationship to the investigational medical device.

  Adverse events with causal relationship to the investigational medical device (judged as 'related', 'possibly related' or 'relationship not assessable') will be evaluated with respect to type, incidence and intensity up to study termination of each subject.

  Up to 2 years (plus or minus 14 days) after surgery.

Secondary Outcomes (39)

• All adverse events without causal relationship to the investigational medical device.

  Up to 2 years (plus or minus 14 days) after surgery.

• Joint girth measurement

  Baseline

• Joint girth measurement

  On Day 180 (plus or minus 14 days) after surgery.

• Joint girth measurement

  On Day 360 (plus or minus 14 days) after surgery.

• Joint girth measurement

  On Day 5 after surgery.

Study Arms (1)

HYTOP®

EXPERIMENTAL

Device: HYTOP®

Interventions

HYTOP® DEVICE

HYTOP® will be implanted once during surgery.

HYTOP®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients between 18 and 50 years of age.
• Good general health condition.
• Signed written informed consent.
• General anaesthesia is justifiable for the patient from the medical point of view.
• Focal chondral defects involving the femorotibial compartment of the knee joint localised in only one compartment and not larger than the size of one HYTOP® patch.
• Isolated one-sided chondral lesion.
• Cartilage defect classified as Outerbridge grade 3 or 4.
• Chondral lesions not exceeding through the subchondral bone (intact subchondral bone).
• Nearly intact chondral structure surrounding the defect, specifically Outerbridge grade 2 or less.
• Corresponding joint area classified with maximum Outerbridge grade 2.
• Clinical symptoms in the target joint (pain on walking 100 m of more than 4 on an 11-point numerical scale or swelling or locking or 'giving way').
• Ensured compliance of subjects over the whole study period.

You may not qualify if:

• Treatment with any investigational product within 4 weeks prior to study entry.
• Patients with known hypersensitivity to the constituents of the product or any component or procedure used in the study.
• Patients with previous treatment of the study relevant defect site.
• Cartilage lesion is not intact shouldered, has bipolar or corresponding involvement or bipolar 'kissing' lesions.
• Necessity of cartilage repair treatment at bilateral joints.
• Patients with meniscus lesions, total or partial (more than 1/3 of total volume) resected meniscus, limited joint mobility, varus/valgus joint malalignment of more than 5 degrees or insufficient ligament support.
• Inflammatory joint diseases (e.g. rheumatoid arthritis, Bechterew disease, chondromatosis).
• Infection at study relevant site.
• Osteoarthritis, arthrofibrosis or haematopoetic related diseases.
• Study relevant metabolic disease, adipositas (BMI equal to or greater 30 kilogram per square meter).
• Study relevant neoplastic, neurological or mental illness.
• Study relevant autoimmune disease.
• Patients with elevated risk of bleeding.
• Recent history of drug and/or alcohol abuse (within the last 6 months).
• Pregnant or lactating females.

Sponsors & Collaborators

• TRB Chemedica AG: lead

Study Sites (1)

Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie

Osnabrück, Lower Saxony, 49076, Germany

Location

Study Officials

• Martin Engelhardt, Dr.

  Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück (Germany)

  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: February 11, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

DE (1)