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

NCT01477008 | Completed DMC

• 2 other identifiers: CR09-0069907776
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 11

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.

Conditions

Chondral or Osteochondral Lesion of Medial Femoral Condyle; Chondral or Osteochondral Lesion of Lateral Femoral Condyle; Chondral or Osteochondral Lesion of Trochlea

Keywords

Knee; Cartilage repair; Cartilage regeneration; Chondral; Osteochondral; Biphasic scaffold; Medical device; Autologous; Synthetic; Medial condyle; Lateral condyle; Trochlea

Outcome Measures

Primary Outcomes (1)

• IKDC-2000 Subjective Knee Evaluation

  Subjective evaluation of knee pain and function (will be captured at preop and each postop visit through 12 months)

  12 months

Secondary Outcomes (8)

• IKDC-2000 Knee Examination Form

  Preop, 6 weeks, 3 months, 6 months, and 12 months

• IKDC-2000 Current Health Assessment Form

  Preop, 6 weeks, 3 months, 6 months, and 12 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Preop, 6 weeks, 3 months, 6 months, and 12 months

• Pain (VAS): sitting, standing, and squatting

  Preop, 6 weeks, 3 months, 6 months, and 12 months

• Magnetic Resonance Imagining (MRI)

  Preop and 12 months

Study Arms (2)

BiCRI

EXPERIMENTAL

BiPhasic Cartilage Repair Implant

Device: BiPhasic Cartilage Repair Implant

Marrow Stimulation

ACTIVE COMPARATOR

Microfracture or Subchondral Drilling

Procedure: Marrow Stimulation

Interventions

BiPhasic Cartilage Repair Implant DEVICE

1 or 2 BiCRI devices, depending on lesion size

BiCRI

Marrow Stimulation PROCEDURE

Microfracture or Subchondral Drilling

Marrow Stimulation

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• ≥ 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.

Sponsors & Collaborators

• BioGend Therapeutics Co.Ltd: lead

Study Sites (11)

Taipei Medical University-Shuang Ho Hospital

Taipei County, Taipei, Taiwan

Location

Show Chwan Memorial Hospital (SCMH)

Changhua, Taiwan

Location

Chang Gung Memorial Hospital Kaohsiung (CGMH-KS)

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital Linkou (CGMH-LK)

Linkou District, Taiwan

Location

China Medical University Hospital (CMUH)

Taichung, Taiwan

Location

Veterans General Hospital Taichung (VGHTC)

Taichung, Taiwan

Location

National Cheng Kung University Medical Center (NCKUMC)

Tainan, Taiwan

Location

National Taiwan University Hospital (NTUH)

Taipei, Taiwan

Location

Shuang Ho Hospital (SHH)

Taipei, Taiwan

Location

Taipei Tzu Chi Hospital (TTCH)

Taipei, Taiwan

Location

Tri-Service General Hospital (TSGH)

Taipei, Taiwan

Location

Related Publications (2)

• Kuo YY, Chiu SQ, Chang WP, Chen CY, Chen CH, Liaw CK, Tan CA, Weng PW. A prospective randomized controlled trial comparing biphasic cartilage repair implant with microfracture in small chondral lesions of knee: findings at five-year-follow-up. J Orthop Surg Res. 2025 Jan 20;20(1):73. doi: 10.1186/s13018-024-05392-6.

  PMID: 39833829 DERIVED

• Tseng TH, Chen CP, Jiang CC, Weng PW, Chan YS, Hsu HC, Chiang H. Biphasic cartilage repair implant versus microfracture in the treatment of focal chondral and osteochondral lesions of the knee: a prospective, multi-center, randomized clinical trial. J Orthop Traumatol. 2024 Nov 30;25(1):62. doi: 10.1186/s10195-024-00802-1.

  PMID: 39614986 DERIVED

Study Officials

• Gwen Chang, MS

  BioGend Therapeutics Co.Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 22, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

TW (11)