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

Not Applicable

Completed

• Conditions: Chondral or Osteochondral Lesion of Medial Femoral Condyle; Chondral or Osteochondral Lesion of Lateral Femoral Condyle; Chondral or Osteochondral Lesion of Trochlea
• Interventions: Device: BiPhasic Cartilage Repair Implant; Procedure: Marrow Stimulation

• Registration Number: NCT01477008
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2019-04
• Study Completion: 2019-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BiCRI	BiPhasic Cartilage Repair Implant	BiPhasic Cartilage Repair Implant
Marrow Stimulation	Marrow Stimulation	Microfracture or Subchondral Drilling

Primary Outcome Measures

Name	Time	Method
IKDC-2000 Subjective Knee Evaluation	12 months	Subjective evaluation of knee pain and function (will be captured at preop and each postop visit through 12 months)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Treatment through 12 months	Documentation of all adverse events from treatment through the end of the study.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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
Arthroscopy with biopsy	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.
IKDC-2000 Knee Examination Form	Preop, 6 weeks, 3 months, 6 months, and 12 months	Objective evaluation of knee pain and function
IKDC-2000 Current Health Assessment Form	Preop, 6 weeks, 3 months, 6 months, and 12 months	Subjective evaluation of quality of life (QOL) and activities of daily living (ADL)
Radiographs	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
Magnetic Resonance Imagining (MRI)	Preop and 12 months	MRI to evaluate cartilage and bone condition
Pain (VAS): sitting, standing, and squatting	Preop, 6 weeks, 3 months, 6 months, and 12 months	Subjective evaluation of pain during routine activities

Trial Locations

Locations (11)

Chang Gung Memorial Hospital Kaohsiung (CGMH-KS); 🇨🇳 Kaohsiung, Taiwan

Shuang Ho Hospital (SHH); 🇨🇳 Taipei, Taiwan

China Medical University Hospital (CMUH); 🇨🇳 Taichung, Taiwan

Taipei Tzu Chi Hospital (TTCH); 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital Linkou (CGMH-LK); 🇨🇳 Linkou, Taiwan

Veterans General Hospital Taichung (VGHTC); 🇨🇳 Taichung, Taiwan

National Cheng Kung University Medical Center (NCKUMC); 🇨🇳 Tainan, Taiwan

Tri-Service General Hospital (TSGH); 🇨🇳 Taipei, Taiwan

Taipei Medical University-Shuang Ho Hospital; 🇨🇳 Taipei county, Taipei, Taiwan

Show Chwan Memorial Hospital (SCMH); 🇨🇳 Changhua, Taiwan

National Taiwan University Hospital (NTUH); 🇨🇳 Taipei, Taiwan