Chondral or Osteochondral Lesion of Medial Femoral CondyleNCT01477008

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

A study testing BiPhasic Cartilage Repair Implant and Marrow Stimulation in people with Chondral or Osteochondral Lesion of Medial Femoral Condyle and Chondral or Osteochondral Lesion of Lateral Femoral Condyle, run by BioGend Therapeutics Co.Ltd at 11 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages Up to 55 years
Conditions the study is for: Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
What is being tested?: BiPhasic Cartilage Repair Implant and Marrow Stimulation
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 11 sitesTaiwan
Study dates: Oct 2011to Aug 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 55 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

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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

Who cannot join

≥ 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

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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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Taiwan11 sites

Show Chwan Memorial Hospital (SCMH)
Changhua
Chang Gung Memorial Hospital Kaohsiung (CGMH-KS)
Kaohsiung City
Chang Gung Memorial Hospital Linkou (CGMH-LK)
Linkou District
China Medical University Hospital (CMUH)
Taichung
Veterans General Hospital Taichung (VGHTC)
Taichung
National Cheng Kung University Medical Center (NCKUMC)
Tainan
National Taiwan University Hospital (NTUH)
Taipei
Shuang Ho Hospital (SHH)
Taipei
Taipei Tzu Chi Hospital (TTCH)
Taipei
Tri-Service General Hospital (TSGH)
Taipei
Taipei Medical University-Shuang Ho Hospital
Taipei County, Taipei

Other trials in Taiwan

About this study

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

Conditions: Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
Being tested: BiPhasic Cartilage Repair Implant, Marrow Stimulation
Keywords: Knee, Cartilage repair, Cartilage regeneration, Chondral, Osteochondral, Biphasic scaffold, Medical device, Autologous, Synthetic, Medial condyle, Lateral condyle, Trochlea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BiPhasic Cartilage Repair ImplantDevice
1 or 2 BiCRI devices, depending on lesion size
Marrow StimulationProcedure or surgery
Microfracture or Subchondral Drilling

Study groups in NCT01477008
Study group	Role	What they receive
BiCRI	Experimental	BiPhasic Cartilage Repair Implant Receives: Device: BiPhasic Cartilage Repair Implant
Marrow Stimulation	Active comparator	Microfracture or Subchondral Drilling Receives: Procedure: Marrow Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Aug 2019

First posted22 Nov 2011 (estimated)
Study startOct 2011
Primary completionApr 2019
Study completionAug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chondral or Osteochondral Lesion of Medial Femoral CondyleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01477008
Sponsor's protocol ID: CR09-006
Other IDs: 9907776
Status last verified: Jan 2022
First submitted: 14 Nov 2011
Last updated: 20 Jan 2022
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 39833829
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.
PubMed 39614986
Chen CP, Weng PW, Lee KT, Chiang LY, Liao WJ, Shaw L. Biphasic Scaffold Loaded With Autologous Cartilage Yields Better Clinical Outcome and Magnetic Resonance Imaging Filling Compared With Marrow Stimulation for Focal Osteochondral Lesions in the Knee. Arthroscopy. 2025 Mar;41(3):688-699. doi: 10.1016/j.arthro.2024.04.016. Epub 2024 May 7.
PubMed 38719177

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01477008
Acronym / sponsor ID: CR09-006
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: BioGend Therapeutics Co.LtdIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Apr 2019 (actual)
Study completion: Aug 2019 (actual)
First posted: 22 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
BiCRI	Experimental	Device: BiPhasic Cartilage Repair ImplantBiPhasic Cartilage Repair Implant
Marrow Stimulation	Active comparator	Procedure: Marrow StimulationMicrofracture or Subchondral Drilling

Who may qualify

Ages: Up to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

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:
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)

Key exclusion criteria (28 listed)

≥ 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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BiPhasic Cartilage Repair Implant1 or 2 BiCRI devices, depending on lesion size	Device	BiCRI
Marrow StimulationMicrofracture or Subchondral Drilling	Procedure or surgery	Marrow Stimulation

Primary outcome

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)

8 secondary outcomes

IKDC-2000 Knee Examination Form
Time frame: 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
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 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
Magnetic Resonance Imagining (MRI)
Time frame: Preop and 12 months
Radiographs
Time frame: Preop, immediate postop, 6 weeks, 3 months, 6 months, 12 months
Adverse Events
Time frame: Treatment through 12 months
Arthroscopy with biopsy
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
Derived from this study: PubMed 39833829Kuo 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.
Derived from this study: PubMed 39614986Tseng 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.
Derived from this study: PubMed 38719177Chen CP, Weng PW, Lee KT, Chiang LY, Liao WJ, Shaw L. Biphasic Scaffold Loaded With Autologous Cartilage Yields Better Clinical Outcome and Magnetic Resonance Imaging Filling Compared With Marrow Stimulation for Focal Osteochondral Lesions in the Knee. Arthroscopy. 2025 Mar;41(3):688-699. doi: 10.1016/j.arthro.2024.04.016. Epub 2024 May 7.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gwen Chang, MS study director

BioGend Therapeutics Co.Ltd

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IKDC-2000 Subjective Knee Evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01477008, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.