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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
HYTOP® will be implanted once during surgery.
Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie
Osnabrück, Lower Saxony, Germany
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.
Time frame: Up to 2 years (plus or minus 14 days) after surgery.
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.
Time frame: Up to 2 years (plus or minus 14 days) after surgery.
Joint girth measurement
Knee girth measurement as a marker for swelling is taken around the knee at the level of mid-patella as well as 10 centimeters (cm) proximal and distal and documented in cm.
Time frame: Baseline
Joint girth measurement
Knee girth measurement as a marker for swelling is taken around the knee at the level of mid-patella as well as 10 centimeters (cm) proximal and distal and documented in cm.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Joint girth measurement
Knee girth measurement as a marker for swelling is taken around the knee at the level of mid-patella as well as 10 centimeters (cm) proximal and distal and documented in cm.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Joint girth measurement
Knee girth measurement as a marker for swelling is taken around the knee at the level of mid-patella as well as 10 centimeters (cm) proximal and distal and documented in cm.
Time frame: On Day 5 after surgery.
Pain intensity
Intensity of pain on walking 100 meters will be evaluated on 11-point ordinal scale ranging from '0' (no pain) to '10' (extreme pain).
Time frame: Baseline
Pain intensity
Intensity of pain on walking 100 meters will be evaluated on 11-point ordinal scale ranging from '0' (no pain) to '10' (extreme pain).
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Pain intensity
Intensity of pain on walking 100 meters will be evaluated on 11-point ordinal scale ranging from '0' (no pain) to '10' (extreme pain).
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Pain intensity
Intensity of pain on walking 100 meters will be evaluated on 11-point ordinal scale ranging from '0' (no pain) to '10' (extreme pain).
Time frame: On Day 5 after surgery.
Magnetic Resonance Imaging (MRI) Signal intensity
MRI will be assessed with respect to signal intensity of the cartilage repair tissue as 'not isointense', 'isointense' or 'not assessable'.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
MRI Signal intensity
MRI will be assessed with respect to signal intensity of the cartilage repair tissue as 'not isointense', 'isointense' or 'not assessable'.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of lesions
MRI will be assessed with respect to lesions in the cartilage repair tissue as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of lesions
MRI will be assessed with respect to lesions in the cartilage repair tissue as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of subchondral bone oedema
MRI will be assessed with respect to presence of subchondral bone oedema as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: Baseline
Presence of subchondral bone oedema
MRI will be assessed with respect to presence of subchondral bone oedema as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of subchondral bone oedema
MRI will be assessed with respect to presence of subchondral bone oedema as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of subchondral bone cyst
MRI will be assessed with respect to presence of subchondral bone cyst as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: Baseline
Presence of subchondral bone cyst
MRI will be assessed with respect to presence of subchondral bone cyst as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of subchondral bone cyst
MRI will be assessed with respect to presence of subchondral bone cyst as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of effusion
MRI will be assessed with respect to presence of effusion as 'no', 'yes' or 'not assessable'.
Time frame: Baseline
Presence of effusion
MRI will be assessed with respect to presence of effusion as 'no', 'yes' or 'not assessable'.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of effusion
MRI will be assessed with respect to presence of effusion as 'no', 'yes' or 'not assessable'.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Joint girth measurement
Knee girth measurement as a marker for swelling is taken around the knee at the level of mid-patella as well as 10 centimeters (cm) proximal and distal and documented in cm.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Pain intensity
Intensity of pain on walking 100 meters will be evaluated on 11-point ordinal scale ranging from '0' (no pain) to '10' (extreme pain).
Time frame: On Day 720 (plus or minus 14 days) after surgery.
MRI Signal intensity
MRI will be assessed with respect to signal intensity of the cartilage repair tissue as 'not isointense', 'isointense' or 'not assessable'.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of lesions
MRI will be assessed with respect to lesions in the cartilage repair tissue as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of subchondral bone oedema
MRI will be assessed with respect to presence of subchondral bone oedema as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of subchondral bone cyst
MRI will be assessed with respect to presence of subchondral bone cyst as 'absent', 'minimal', 'moderate', 'severe' or 'not assessable'.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of effusion
MRI will be assessed with respect to presence of effusion as 'no', 'yes' or 'not assessable'.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
The KOOS score consists of five separate scores calculated for pain, symptoms, activities of daily living, sport and recreational function and knee-related quality of life. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The results can be plotted as an outcome profile.
Time frame: Baseline
Knee injury and osteoarthritis outcome score (KOOS)
The KOOS score consists of five separate scores calculated for pain, symptoms, activities of daily living, sport and recreational function and knee-related quality of life. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The results can be plotted as an outcome profile.
Time frame: On Day 5 after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
The KOOS score consists of five separate scores calculated for pain, symptoms, activities of daily living, sport and recreational function and knee-related quality of life. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The results can be plotted as an outcome profile.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
The KOOS score consists of five separate scores calculated for pain, symptoms, activities of daily living, sport and recreational function and knee-related quality of life. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The results can be plotted as an outcome profile.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
The KOOS score consists of five separate scores calculated for pain, symptoms, activities of daily living, sport and recreational function and knee-related quality of life. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The results can be plotted as an outcome profile.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Subjective knee evaluation form
The Subjective knee evaluation form of the International Knee Documentation Committee (IKDC) is used to assess symptoms, knee function and sporting activities in patients. The form consists of 18 questions in the domains of symptoms, functioning during activity of daily living and sports, current function of the knee, and participation in work and sports.
Time frame: Baseline
Subjective knee evaluation form
The Subjective knee evaluation form of the International Knee Documentation Committee (IKDC) is used to assess symptoms, knee function and sporting activities in patients. The form consists of 18 questions in the domains of symptoms, functioning during activity of daily living and sports, current function of the knee, and participation in work and sports.
Time frame: On Day 5 after surgery.
Subjective knee evaluation form
The Subjective knee evaluation form of the International Knee Documentation Committee (IKDC) is used to assess symptoms, knee function and sporting activities in patients. The form consists of 18 questions in the domains of symptoms, functioning during activity of daily living and sports, current function of the knee, and participation in work and sports.
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Subjective knee evaluation form
The Subjective knee evaluation form of the International Knee Documentation Committee (IKDC) is used to assess symptoms, knee function and sporting activities in patients. The form consists of 18 questions in the domains of symptoms, functioning during activity of daily living and sports, current function of the knee, and participation in work and sports.
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Subjective knee evaluation form
The Subjective knee evaluation form of the International Knee Documentation Committee (IKDC) is used to assess symptoms, knee function and sporting activities in patients. The form consists of 18 questions in the domains of symptoms, functioning during activity of daily living and sports, current function of the knee, and participation in work and sports.
Time frame: On Day 720 (plus or minus 14 days) after surgery.
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