BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Exactech Taiwan, Ltd.
Sponsor:
Collaborator:
Exactech, Inc.
Information provided by (Responsible Party):
Exactech Taiwan, Ltd.
ClinicalTrials.gov Identifier:
NCT01477008
First received: November 14, 2011
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI, Exactech Taiwan) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial femoral condyle, lateral femoral condyle, or trochlea of the knee. The hypothesis is that the BiCRI provides an improvement in pain and function as compared to baseline, that is no worse than marrow stimulation at 1 year.


Condition Intervention Phase
Chondral or Osteochondral Lesion of Medial Femoral Condyle
Chondral or Osteochondral Lesion of Lateral Femoral Condyle
Chondral or Osteochondral Lesion of Trochlea
Device: BiPhasic Cartilage Repair Implant
Procedure: Marrow Stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Exactech Taiwan, Ltd.:

Primary Outcome Measures:
  • IKDC-2000 Subjective Knee Evaluation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjective evaluation of knee pain and function (will be captured at preop and each postop visit through 12 months)


Secondary Outcome Measures:
  • IKDC-2000 Knee Examination Form [ Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Objective evaluation of knee pain and function

  • IKDC-2000 Current Health Assessment Form [ Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Subjective evaluation of quality of life (QOL) and activities of daily living (ADL)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
    A subjective instrument to assess the subject's opinion about their knee and associated problems

  • Pain (VAS): sitting, standing, and squatting [ Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Subjective evaluation of pain during routine activities

  • Magnetic Resonance Imagining (MRI) [ Time Frame: Preop and 12 months ] [ Designated as safety issue: No ]
    MRI to evaluate cartilage and bone condition

  • Radiographs [ Time Frame: Preop, immediate postop, 6 weeks, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

    Not all views taken at each time frame.

    • Weight bearing full extension AP view (both knees)
    • Rosenberg view (45 degree PA flexion weight bearing, both knees)
    • Lateral view of involved knee
    • Sunrise (skyline) view of involved knee

  • Adverse Events [ Time Frame: Treatment through 12 months ] [ Designated as safety issue: Yes ]
    Documentation of all adverse events from treatment through the end of the study.

  • Arthroscopy with biopsy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 92
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BiCRI
BiPhasic Cartilage Repair Implant
Device: BiPhasic Cartilage Repair Implant
1 or 2 BiCRI devices, depending on lesion size
Active Comparator: Marrow Stimulation
Microfracture or Subchondral Drilling
Procedure: Marrow Stimulation
Microfracture or Subchondral Drilling

  Eligibility

Ages Eligible for Study:   up to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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
  2. Skeletally mature (epiphyses are confirmed to be closed on x-ray)
  3. ICRS grade 3-4 lesion, Outerbridge grade 4, or OCD grades 3-4
  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.
  5. 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)
  6. Willing and able to return for follow-up over a one year post-operative period
  7. Willing and able to comply with all postoperative guidelines

Exclusion Criteria

  1. ≥ 55 years old
  2. Lesions > grade II on the articular surface of the tibia or patella
  3. 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.
  4. Prior surgical treatment of the lesion
  5. 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
  6. Lesion will require bone grafting
  7. Rheumatoid arthritis and other inflammatory arthritis
  8. 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°
  9. Body Mass Index (BMI) > 35.0
  10. Local or systemic infection, not including asymptomatic urinary tract infection if treated with antibiotics preoperatively
  11. Pregnancy or breast feeding
  12. Prisoner
  13. Patient is involved in a personal litigation (e.g. Worker's Compensation lawsuit) that relates to their knee surgery
  14. Patient is actively participating in another medical device, drug, or biologic investigation (active defined as within the last 30 days)
  15. Patient otherwise meets the study criteria but refuses to consent in writing to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477008

Contacts
Contact: Brian Chen, PhD +886 0983599996 brian.chen@exac.com
Contact: Matt Christensen +1-352-327-4665 matt.christensen@exac.com

Locations
Taiwan
Chang Bing Show Chwan Memorial Hospital (CBSCMH) Recruiting
Changhua, Taiwan
Contact: Tai-Sheng Tan, MD    +886-4-7813888 ext 71086    tedtstan@ms74.hinet.net   
Principal Investigator: Tai-Sheng Tan, MD         
Show Chwan Memorial Hospital (SCMH) Recruiting
Changhua, Taiwan
Contact: Chien-Sheng Lo, MD    +886-4-7256166    johnlcs317@gmail.com   
Contact       lhj@csmu.edu.tw   
Principal Investigator: Chien-Sheng Lo, MD         
Chang Gung Memorial Hospital Kaohsiung (CGMH-KS) Recruiting
Kaohsiung, Taiwan
Contact: Ching-Jen Wang, MD    +886-7-7317123 ext 2076    w281211@adm.cgmh.org.tw   
Principal Investigator: Ching-Jen Wang, MD         
Chang Gung Memorial Hospital Keelung (CGMH-KL) Withdrawn
Keelung, Taiwan
Chang Gung Memorial Hospital Linkou (CGMH-LK) Recruiting
Linkou, Taiwan
Contact: Yi-Sheng Chan, MD    +886-3-3281200 ext 3882    chan512@adm.cgmh.org.tw   
Principal Investigator: Yi-Sheng Chan, MD         
China Medical University Hospital (CMUH) Recruiting
Taichung, Taiwan
Contact: Horng-Chaung Hsu, MD    +886-4-22052121 ext 5052    d4749@mail.cmuh.org.tw   
Principal Investigator: Horng-Chaun Hsu, MD         
Veterans General Hospital Taichung (VGHTC) Recruiting
Taichung, Taiwan
Contact: Kui-Chou Huang, MD    +886-4-23592525 ext 5101    kuichouhuang@vghtc.gov.tw   
Principal Investigator: Kui-Chou Huang, MD         
National Cheng Kung University Medical Center (NCKUMC) Recruiting
Tainan, Taiwan
Contact: Chyun-Yu Yang, MD    +886-6-2353535 ext 2013    cyyang@mail.ncku.edu.tw   
Principal Investigator: Chyun-Yu Yang, MD         
National Taiwan University Hospital (NTUH) Recruiting
Taipei, Taiwan
Contact: Hong-Sen Chiang, MD, PhD    +886-2-23123456    hongsen@ntu.edu.tw   
Principal Investigator: Hong-Sen Chiang, MD, PhD         
Sub-Investigator: Ching-Chuan Jiang, MD, PhD         
Veterans General Hospital Taipei (VGHTP) Withdrawn
Taipei, Taiwan
Taipei Medical University Hospital (TMUH) Recruiting
Taipei, Taiwan
Contact: Chian-Her Lee, MD    +886-2-27372181 ext 3740    chianherlee@yahoo.com.tw   
Principal Investigator: Chian-Her Lee, MD         
Tri-Service General Hospital (TSGH) Recruiting
Taipei, Taiwan
Contact: Leou-Chyr Lin, MD    +886-2-87923311 ext 88081    lchlin66@hotmail.com   
Principal Investigator: Leou-Chyr Lin, MD         
Sponsors and Collaborators
Exactech Taiwan, Ltd.
Exactech, Inc.
Investigators
Study Director: Matthew Christensen, CCRA Exactech
  More Information

Additional Information:
No publications provided

Responsible Party: Exactech Taiwan, Ltd.
ClinicalTrials.gov Identifier: NCT01477008     History of Changes
Other Study ID Numbers: CR09-006, 9907776
Study First Received: November 14, 2011
Last Updated: May 9, 2013
Health Authority: Taiwan: Taiwan Food and Drug Administration

Keywords provided by Exactech Taiwan, Ltd.:
Knee
Cartilage repair
Cartilage regeneration
Chondral
Osteochondral
Biphasic scaffold
Medical device
Autologous
Synthetic
Medial condyle
Lateral condyle
Trochlea

ClinicalTrials.gov processed this record on October 21, 2014