Status:
COMPLETED
Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects
Lead Sponsor:
co.don AG
Conditions:
Articular Cartilage Lesion of the Femoral Condyle
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
This is a prospective, phase III, multicenter, open label, randomised clinical trial of co.don chondrosphere®, a three-dimensional autologous chondrocyte transplantation product (ACT3D-CS)compared to ...
Detailed Description
see above
Eligibility Criteria
Inclusion
- Male or female patients, age: between 18 and 50 years
- Defect: isolated ICRS grade III or IV single defect chondral lesions on femoral condyles
- Defect size: 1 to \< 4 cm2 after debridement to healthy cartilage up to 6 mm in depth.Assessment with MRI at screening and per estimation during arthroscopy prior to randomization
- Nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area
- Informed consent signed and dated by patient
- Patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it
- In case of pain, patient agrees to use only paracetamol mono- (max 4 g/day) or combination preparation and oral and/or topic NSAIDs during the trial and to discontinue the use of oral and/or topic NSAIDs and/or paracetamol combination preparation 1 week before each visit whereas the use of paracetamol monopreparation (max 4 g/day) is allowed. However, in the morning of the visit day, no pain medication is allowed. Other pain medications are allowed during surgical procedure and may be taken for a period not exceeding 4 weeks after surgery.
Exclusion
- Defects on both knees at the same time
- Radiological signs of osteoarthritis
- Osteochondritis dissecans (OCD)
- Any signs of knee instability
- Valgus or varus malalignment (more than 5° over the mechanical axis)
- Clinically relevant second cartilage lesion on the same knee
- More than 50 % resection of a meniscus in the affected knee or incomplete meniscal rim
- Rheumatoid arthritis, parainfectious or infectious arthritis, and condition after these diseases
- Pregnancy and planned pregnancy (no MRI possible)
- Obesity (Body Mass Index \>30)
- Uncontrolled diabetes mellitus
- Serious illness
- Poor general health as judged by physician
- Participation in concurrent clinical trials or previous trials within 3 months of screening
- Previous treatment with ACT in the affected knee
- Microfracture performed less than 1 year before screening in the affected knee
- Alcohol or drug (medication) abuse
- Meniscal transplant in the affected knee
- Meniscal suture (in the affected knee) three months prior to baseline
- Mosaicplasty (Osteoarticular Transplant System, OATS) in the affected knee
- Having received hyaluronic acid intra-articular injections in the affected knee within the last 3 months before baseline
- Taking specific osteoarthritis drugs such as chondroïtin sulfate, diacerein, nglucosamine,piascledine, capsaicin within 2 weeks before baseline
- Corticosteroid treatment by systemic or intraarticular route within the last month of baseline or intramuscular or oral corticosteroïds within the last 2 weeks before baseline
- Chronic use of anticoagulants
- Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
- Any clinically significant or symptomatic vascular or neurological disorder of the lower extremities
- Any evidence of the following diseases in the affected knee: septic arthritis, inflammatory joint disease, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, haemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
- Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1,-2) and/or hepatitis C virus (HCV) infection
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01222559
Start Date
October 1 2010
End Date
February 1 2020
Last Update
January 27 2021
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum der Albert-Ludwig-Universität Freiburg, Department Othopädie und Traumatologie
Freiburg im Breisgau, Baden-Würrtemberg, Germany, 79106
2
Waldkrankenhaus "Rudolf Elle" GmbH Klinik für Orthopädie und Unfallchirurgie
Eisenberg, Tühringen, Germany, 07607
3
Gelenk-und Wirbelsäulenzentrum Steglitz
Berlin, Germany, 12163
4
DRK-Kliniken Westend
Berlin, Germany, 14050