Focal Chondral Defect in Femoro-tibial Compartment of the Knee JointNCT01791062
Safety and Efficacy Study of HYTOP® in the Treatment of Focal Chondral Defects.
A study testing HYTOP® in people with Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint, run by TRB Chemedica AG at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint
- What is being tested?
- HYTOP®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Oct 2016
- 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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie
Osnabrück, Lower Saxony, 49076
About this study
Official title: Safety and Efficacy of a Novel, Cell-free Cartilage Repair Construct in the Treatment of Focal Chondral Defects Involving the Femoro-tibial Compartment of the Knee Joint.
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.
- Being tested
- HYTOP®
- Keywords
- cartilage tissue engineering, hyaluronan, hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYTOP®Device
HYTOP® will be implanted once during surgery.
| Study group | Role | What they receive |
|---|---|---|
| HYTOP® | Experimental | Not described Receives: Device: HYTOP® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: Baseline
Presence of effusion
MRI will be assessed with respect to presence of effusion as 'no', 'yes' or 'not assessable'.
Measured: 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'.
Measured: 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.
Measured: 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).
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On Day 720 (plus or minus 14 days) after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Chondral Defect in Femoro-tibial Compartment of 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Engelhardt, Dr., Principal investigator, Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791062
- Sponsor's protocol ID
- CAREKT-DE-2011-12
- Status last verified
- Nov 2016
- First submitted
- 11 Feb 2013
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Novel, Cell-free Cartilage Repair Construct in the Treatment of Focal Chondral Defects Involving the Femoro-tibial Compartment of the Knee Joint.
- ClinicalTrials.gov ID
- NCT01791062
- Acronym / sponsor ID
- CAREKT-DE-2011-12
- Keywords
- cartilage tissue engineering, hyaluronan, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Feb 2013 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYTOP® | Experimental | Device: HYTOP® |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| HYTOP®HYTOP® will be implanted once during surgery. | Device | HYTOP® |
Primary outcome
Number of adverse events with causal relationship to the investigational medical device.
Time frame: Up to 2 years (plus or minus 14 days) after surgery.
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.
39 secondary outcomes
All adverse events without causal relationship to the investigational medical device.
Time frame: Up to 2 years (plus or minus 14 days) after surgery.
Joint girth measurement
Time frame: Baseline
Joint girth measurement
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Joint girth measurement
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Joint girth measurement
Time frame: On Day 5 after surgery.
Pain intensity
Time frame: Baseline
Pain intensity
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Pain intensity
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Pain intensity
Time frame: On Day 5 after surgery.
Magnetic Resonance Imaging (MRI) Signal intensity
Time frame: On Day 180 (plus or minus 14 days) after surgery.
MRI Signal intensity
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of lesions
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of lesions
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of subchondral bone oedema
Time frame: Baseline
Presence of subchondral bone oedema
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of subchondral bone oedema
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of subchondral bone cyst
Time frame: Baseline
Presence of subchondral bone cyst
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of subchondral bone cyst
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Presence of effusion
Time frame: Baseline
Presence of effusion
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Presence of effusion
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Joint girth measurement
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Pain intensity
Time frame: On Day 720 (plus or minus 14 days) after surgery.
MRI Signal intensity
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of lesions
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of subchondral bone oedema
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of subchondral bone cyst
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Presence of effusion
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: Baseline
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: On Day 5 after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Subjective knee evaluation form
Time frame: Baseline
Subjective knee evaluation form
Time frame: On Day 5 after surgery.
Subjective knee evaluation form
Time frame: On Day 180 (plus or minus 14 days) after surgery.
Subjective knee evaluation form
Time frame: On Day 360 (plus or minus 14 days) after surgery.
Subjective knee evaluation form
Time frame: On Day 720 (plus or minus 14 days) after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
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.
Martin Engelhardt, Dr. principal investigator
Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück (Germany)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYTOP® in people with Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint, run by TRB Chemedica AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of adverse events with causal relationship to the investigational medical device. (time frame: Up to 2 years (plus or minus 14 days) after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2016.