Safety and Efficacy Study of HYTOP® in the Treatment of F... | NCT01791062

NCT01791062

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
HYTOP®	Experimental		Device: HYTOP®

Name	Type	Description	Arm Group Labels	Other Names
HYTOP®	Device	HYTOP® will be implanted once during surgery.	HYTOP®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
All adverse events without causal relationship to the investigational medical device.	Adverse events without causal relationship to the investigational medical device (judged as 'not related') 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index more than 1% (e.g. oral contraceptives, vaginal ring, hormone-releasing intrauterine device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,…) during the treatment period and the first 12 weeks of follow-up period.
Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and/or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language).
Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
Low probability of compliance with after-care rehabilitation scheme.
Forbidden concomitant treatment affecting the evaluation of study parameters (e.g. oral intake of chondroitin sulfate, glucosamine, piascledine, other i.a. treatments like depot corticosteroids or arthroscopic procedures).