ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01477008
Recruitment Status : Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
BioGend Therapeutics Co.Ltd

Brief Summary:
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) 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 or disease Intervention/treatment 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : October 2011
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. IKDC-2000 Knee Examination Form [ Time Frame: Preop, 6 weeks, 3 months, 6 months, and 12 months ]
    Objective evaluation of knee pain and function

  2. 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)

  3. 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

  4. 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

  5. Magnetic Resonance Imagining (MRI) [ Time Frame: Preop and 12 months ]
    MRI to evaluate cartilage and bone condition

  6. Radiographs [ Time Frame: Preop, immediate postop, 6 weeks, 3 months, 6 months, 12 months ]

    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

  7. Adverse Events [ Time Frame: Treatment through 12 months ]
    Documentation of all adverse events from treatment through the end of the study.

  8. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477008


Locations
Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei county, Taipei, Taiwan
Show Chwan Memorial Hospital (SCMH)
Changhua, Taiwan
Chang Gung Memorial Hospital Kaohsiung (CGMH-KS)
Kaohsiung, Taiwan
Chang Gung Memorial Hospital Linkou (CGMH-LK)
Linkou, Taiwan
China Medical University Hospital (CMUH)
Taichung, Taiwan
Veterans General Hospital Taichung (VGHTC)
Taichung, Taiwan
National Cheng Kung University Medical Center (NCKUMC)
Tainan, 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, Taiwan
Sponsors and Collaborators
BioGend Therapeutics Co.Ltd
Investigators
Study Chair: Brian Chen, PhD BioGend Therapeutics Co.Ltd

Responsible Party: BioGend Therapeutics Co.Ltd
ClinicalTrials.gov Identifier: NCT01477008     History of Changes
Other Study ID Numbers: CR09-006
9907776 ( Other Identifier: Taiwan FDA - IDE # )
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Keywords provided by BioGend Therapeutics Co.Ltd:
Knee
Cartilage repair
Cartilage regeneration
Chondral
Osteochondral
Biphasic scaffold
Medical device
Autologous
Synthetic
Medial condyle
Lateral condyle
Trochlea