- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01477008
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
A Prospective, Multi-Center, Randomized Clinical Trial Comparing the Biphasic Cartilage Repair Implant to Marrow Stimulation in the Treatment of Focal Chondral and Osteochondral Lesions of the Knee
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Changhua, Taiwan
- Show Chwan Memorial Hospital (SCMH)
-
Kaohsiung, Taiwan
- Chang Gung Memorial Hospital Kaohsiung (CGMH-KS)
-
Linkou, Taiwan
- Chang Gung Memorial Hospital Linkou (CGMH-LK)
-
Taichung, Taiwan
- China Medical University Hospital (CMUH)
-
Taichung, Taiwan
- Veterans General Hospital Taichung (VGHTC)
-
Tainan, Taiwan
- National Cheng Kung University Medical Center (NCKUMC)
-
Taipei, Taiwan
- National Taiwan University Hospital (NTUH)
-
Taipei, Taiwan
- Shuang Ho Hospital (SHH)
-
Taipei, Taiwan
- Taipei Tzu Chi Hospital (TTCH)
-
Taipei, Taiwan
- Tri-Service General Hospital (TSGH)
-
-
Taipei
-
Taipei county, Taipei, Taiwan
- Taipei Medical University-Shuang Ho Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Male or female presenting with a single, symptomatic chondral or osteochondral lesion of the medial or lateral femoral condyles or the trochlea requiring primary surgical intervention
- Skeletally mature (epiphyses are confirmed to be closed on x-ray)
- ICRS grade 3-4 lesion, Outerbridge grade 4, or OCD grades 3-4
Lesion size requires no more than 2 implants (assuming patient were to be randomized to the treatment group). Lesion size will be assessed at the time of the study procedure for all subjects. If the size of the lesion is appropriate for 1 or 2 implants the patient will be randomized. If the lesion is found to be too large the patient will not be included in the trial, but will be treated according to standard of care. Lesion sizes that are considered appropriate include the following:
- Lesion is 3mm x 3mm or larger and can be completely covered by the small (12.5mm diameter) sizer (excluding small fissures). This lesion should be treated with 1 implant. or
- Lesion is 3mm x 3mm or larger and cannot be covered by the small sizer, but can be completely covered by the large (oval shaped) sizer (excluding small fissures). This lesion should be treated with 2 implants.
- Willing and able to refrain from taking pain medications (including: narcotic and non-steroidal anti-inflammatory drugs) for 7 days prior to the baseline preoperative visit and for 7 days prior to the 12-month postoperative visit (i.e., a "wash out" period)
- Willing and able to return for follow-up over a one year post-operative period
- Willing and able to comply with all postoperative guidelines
Exclusion Criteria
- ≥ 55 years old
- Lesions > grade II on the articular surface of the tibia or patella
- Kissing lesions (defined as an opposing lesion > grade II on the surface of the tibia or patella). Lesion ≤ grade II on opposing surface would be acceptable.
- Prior surgical treatment of the lesion
Lesion would require more than 2 implants (assuming patient were to be randomized to the treatment group). Lesion sizes that are not considered appropriate include the following:
- Lesion is smaller than 3mm x 3mm
- Lesion cannot be completely covered by the large sizer
- Lesion will require bone grafting
- Rheumatoid arthritis and other inflammatory arthritis
Concomitant comorbidities, such as:
- ACL instability that will not be corrected before or during the study procedure ("ACL instability" defined as the presence of a positive "pivot shift" test)
- Significant knee instability that will not be corrected before or during the study procedure
Significant malalignment (varus or valgus deformity, patellar malalignment) that will not be corrected before or during the study procedure. Significant malalignment defined as:
- Any joint space narrowing as compared to the same compartment in the contralateral knee.
- Mechanical axis alignment outside the tibial spines.
- Patellofemoral subluxation on sunrise view.
- History of patellar dislocation or subluxation.
- Severe meniscal damage ("Severe meniscal damage" defined as > 50% of the meniscus missing or a radial tear extending to the meniscal-synovial junction)
Knee stiffness, defined as:
- Flexion contracture >10°
- Flexion degree < 115°
- Body Mass Index (BMI) > 35.0
- Local or systemic infection, not including asymptomatic urinary tract infection if treated with antibiotics preoperatively
- Pregnancy or breast feeding
- Prisoner
- Patient is involved in a personal litigation (e.g. Worker's Compensation lawsuit) that relates to their knee surgery
- Patient is actively participating in another medical device, drug, or biologic investigation (active defined as within the last 30 days)
- Patient otherwise meets the study criteria but refuses to consent in writing to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BiCRI
BiPhasic Cartilage Repair Implant
|
1 or 2 BiCRI devices, depending on lesion size
|
Active Comparator: Marrow Stimulation
Microfracture or Subchondral Drilling
|
Microfracture or Subchondral Drilling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IKDC-2000 Subjective Knee Evaluation
Time Frame: 12 months
|
Subjective evaluation of knee pain and function (will be captured at preop and each postop visit through 12 months)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IKDC-2000 Knee Examination Form
Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months
|
Objective evaluation of knee pain and function
|
Preop, 6 weeks, 3 months, 6 months, and 12 months
|
IKDC-2000 Current Health Assessment Form
Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months
|
Subjective evaluation of quality of life (QOL) and activities of daily living (ADL)
|
Preop, 6 weeks, 3 months, 6 months, and 12 months
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months
|
A subjective instrument to assess the subject's opinion about their knee and associated problems
|
Preop, 6 weeks, 3 months, 6 months, and 12 months
|
Pain (VAS): sitting, standing, and squatting
Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months
|
Subjective evaluation of pain during routine activities
|
Preop, 6 weeks, 3 months, 6 months, and 12 months
|
Magnetic Resonance Imagining (MRI)
Time Frame: Preop and 12 months
|
MRI to evaluate cartilage and bone condition
|
Preop and 12 months
|
Radiographs
Time Frame: Preop, immediate postop, 6 weeks, 3 months, 6 months, 12 months
|
Not all views taken at each time frame.
|
Preop, immediate postop, 6 weeks, 3 months, 6 months, 12 months
|
Adverse Events
Time Frame: Treatment through 12 months
|
Documentation of all adverse events from treatment through the end of the study.
|
Treatment through 12 months
|
Arthroscopy with biopsy
Time Frame: 12 months
|
Arthroscopic second look to visualize the repair site.
Biopsy of the cartilage and bone region of the treated site.
Only performed on patients who agree to second procedure.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gwen Chang, MS, BioGend Therapeutics Co.Ltd
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR09-006
- 9907776 (Other Identifier: Taiwan FDA - IDE #)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chondral or Osteochondral Lesion of Medial Femoral Condyle
-
Hyundai Bioland Co., Ltd.Medipost Co Ltd.CompletedChondral or Osteochondral Lesion of TalusKorea, Republic of
-
Fundacion para la Investigacion Biomedica del Hospital...UnknownArticular Cartilage Lesion of the Femoral CondyleSpain
-
Geistlich Pharma AGWithdrawnChondral Defect | Osteochondral Lesion of Talus | MicrofractureUnited Kingdom
-
co.don AGCompletedArticular Cartilage Lesion of the Femoral CondyleGermany, Poland
-
TiGenix n.v.CompletedArticular Cartilage Lesion of the Femoral CondyleBelgium, Croatia, Germany, Netherlands
-
co.don AGCompletedLarge Articular Cartilage Lesions of the Femoral | Condyle, Trochlea, Tibia or RetropatellarGermany
-
Zimmer BiometTerminatedRheumatoid Arthritis | Knee Pain | Chronic Osteoarthritis | Moderate Varus, Valgus or Flexion Deformities | Avascular Necrosis of Femoral CondyleCanada
-
Zimmer BiometCompletedRheumatoid Arthritis | Knee Pain | Chronic Osteoarthritis | Avascular Necrosis of the Femoral Condyle | Moderate Varus, Valgus or Flexion DeformitiesUnited States
-
Zimmer BiometRecruitingRheumatoid Arthritis | Knee Pain | Chronic Osteoarthritis | Avascular Necrosis of the Femoral Condyle | Moderate Varus, Valgus or Flexion DeformitiesBelgium, Germany, Italy, Israel, Switzerland
-
Zimmer BiometCompletedOsteoarthritis | Traumatic Arthritis | Avascular Necrosis of the Femoral Condyle | Moderate Varus | Valgus | Flexion DeformitiesUnited States
Clinical Trials on BiPhasic Cartilage Repair Implant
-
BioGend Therapeutics Co.LtdRecruitingArticular Cartilage Disorder of KneeTaiwan
-
UMC UtrechtCompletedInflammation | Knee Pain Swelling | Foreign-Body Reaction | Effusion (L) KneeNetherlands
-
Askel Healthcare LtdRecruitingCartilage or Osteochondral Defects in the KneeEstonia, Finland, Sweden
-
AlloSourceTerminatedCartilage Injury | Cartilage DamageUnited States
-
Singapore General HospitalUnknownOsteochondritis Dissecans | Other Articular Cartilage DisordersSingapore
-
Kensey Nash CorporationTerminatedArticular Cartilage InjuryUnited States
-
University of OklahomaWithdrawnMetatarsophalangeal Joint Arthritis
-
Smith & Nephew, Inc.TerminatedDefect of Articular CartilageBelgium, Denmark, Germany, Ireland, Netherlands, Norway, Sweden, United Kingdom
-
Philips Clinical & Medical Affairs GlobalCompletedPeripheral Artery DiseaseUnited States, Austria, Netherlands