Articular Cartilage DisorderNCT01410136
Chondrofix Osteochondral Allograft Prospective Study
A study testing Chondrofix Osteochondral Allograft in people with Articular Cartilage Disorder and Degeneration; Articular Cartilage, run by Zimmer Orthobiologics, Inc. at 5 sites in United States.
Trial summary
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury
- What is being tested?
- Chondrofix Osteochondral Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2011to Mar 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally, the following inclusion criteria must be met, however, this is not a complete list.
- Male and non-pregnant female subjects between 18 and 70 years; subject must be skeletally mature
- If female, subjects are not pregnant at time of surgery and do not plan on becoming pregnant during the first 24 months of the study
- Up to two (2) cartilage lesion(s), each measuring less than 8 cm2, of the femoral condyle or trochlear groove of the knee
- Localized knee pain unresponsive to conservative treatment (e.g., medication, bracing, physical therapy) and/or previous surgical intervention
Who cannot join
- Generally, if a potential participant meets any of the following criteria, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
- Concurrent participation in another clinical trial
- Cartilage lesion location is such that the implanted graft(s) will not be adequately shouldered
- Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
- Is receiving pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition
- Subject had any other cartilage repair procedure other than debridement performed in conjunction with or 6 months prior to implantation of a Chondrofix Osteochondral Allograft
Show all 17Show fewer
- Prior or concurrent total meniscectomy of the index knee
- Uncorrected mal-alignment of the index knee
- Have smoked or used nicotine products within the past 6 months
- Body Mass Index > 35 (BMI=kg/m2)
- Has any contraindications for MRI
- Requires any of the following concomitant procedures performed in conjunction with or has had performed within 6 months prior to implantation of a Chondrofix Allograft: distal realignment, high tibial osteotomy, ligament reconstruction, and/or patellar realignment procedure
- Septic or reactive arthritis or systemic disease (e.g., rheumatoid arthritis, gout or prior history of gout or pseudo gout)
- Sickle cell disease, hemochromatosis, or autoimmune disease
- Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes
- HIV or other immune-deficient state including subject on immunosuppressant therapies
- Deficiency limiting ability to perform an objective functional assessment of the operative knee or an inability to adhere to a post-operative rehabilitation protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cartilage Repair Center, Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Specialized Orthopaedics and Sports Medicine
Columbus, Ohio, 43215
Plancher Orthopaedics and Sports Medicine
Cos Cob, Connecticut, 06807
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, 46143
The Orthopaedic Group, LLC
New Haven, Connecticut, 06511
About this study
Official title: A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.
Read the detailed description
Knee cartilage injuries are a major cause of pain and functional impairment in young to middle age adults and can lead to progressive joint degeneration. In response to challenges with current cartilage repair options, Chondrofix Allograft was developed as an off-the-shelf treatment option adding to the variety of cartilage reparation offerings.
This study is a multicenter, prospective, post-market clinical outcomes study designed to assess the clinical outcomes of Chondrofix Allograft used in the treatment of both primary and revision cartilage repair cases. Study design includes up to 6 qualified investigational sites with 50 subjects enrolled across all centers during an 18 month enrollment period. Study subjects will be followed postoperatively for 5 years. The Investigators who are responsible for the conduct of this study in compliance with this protocol will be orthopedic surgeons who are skilled in the techniques of articular cartilage repair.
- Conditions
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury, Defect of Articular Cartilage
- Being tested
- Chondrofix Osteochondral Allograft
- Keywords
- Knee, Femur, Articular cartilage, Lesions, Defects, Osteochondral graft, Cartilage treatments, Osteochondritis Dissecans, OCD
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondrofix Osteochondral AllograftProcedure or surgery
Also called Chondrofix
Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone
| Study group | Role | What they receive |
|---|---|---|
| Chondrofix | Other | Subjects with one or two confirmed knee articular cartilage lesion(s) each less than 8cm2, of the femoral condyle or trochlear groove Receives: Procedure: Chondrofix Osteochondral Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS Subscale
The overall mean change from baseline to 24 months in the KOOS Pain and KOOS Function in Daily Living (ADL) subscale scores.
Measured: 24 Months
Secondary outcomes (3)
X-ray & MRI Evaluation
Measured: Baseline and 1.5, 3, 6, 12, 24, & 60 months
IKDC Knee Examination
Measured: Baseline & 1.5, 3, 6, 12, 24, & 60 months
Subject Reported Questionnaires
Measured: Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Inadequate enrollment and decreased need for clinical data to support product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Orthobiologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikesha N Harrington, Study chair, Zimmer Orthobiologics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410136
- Sponsor's protocol ID
- CSU2010-14B
- Status last verified
- Aug 2014
- First submitted
- 2 Aug 2011
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee
- ClinicalTrials.gov ID
- NCT01410136
- Acronym / sponsor ID
- CSU2010-14B
- Conditions
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury, Defect of Articular Cartilage
- Keywords
- Knee, Femur, Articular cartilage, Lesions, Defects, Osteochondral graft, Cartilage treatments, Osteochondritis Dissecans
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment and decreased need for clinical data to support product
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Zimmer Orthobiologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Aug 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.
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.
Detailed description
Knee cartilage injuries are a major cause of pain and functional impairment in young to middle age adults and can lead to progressive joint degeneration. In response to challenges with current cartilage repair options, Chondrofix Allograft was developed as an off-the-shelf treatment option adding to the variety of cartilage reparation offerings.
This study is a multicenter, prospective, post-market clinical outcomes study designed to assess the clinical outcomes of Chondrofix Allograft used in the treatment of both primary and revision cartilage repair cases. Study design includes up to 6 qualified investigational sites with 50 subjects enrolled across all centers during an 18 month enrollment period. Study subjects will be followed postoperatively for 5 years. The Investigators who are responsible for the conduct of this study in compliance with this protocol will be orthopedic surgeons who are skilled in the techniques of articular cartilage repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chondrofix | Other | Procedure: Chondrofix Osteochondral AllograftSubjects with one or two confirmed knee articular cartilage lesion(s) each less than 8cm2, of the femoral condyle or trochlear groove |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Generally, the following inclusion criteria must be met, however, this is not a complete list.
- Male and non-pregnant female subjects between 18 and 70 years; subject must be skeletally mature
- If female, subjects are not pregnant at time of surgery and do not plan on becoming pregnant during the first 24 months of the study
- Up to two (2) cartilage lesion(s), each measuring less than 8 cm2, of the femoral condyle or trochlear groove of the knee
- Localized knee pain unresponsive to conservative treatment (e.g., medication, bracing, physical therapy) and/or previous surgical intervention
Key exclusion criteria (17 listed)
- Generally, if a potential participant meets any of the following criteria, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
- Concurrent participation in another clinical trial
- Cartilage lesion location is such that the implanted graft(s) will not be adequately shouldered
- Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
- Is receiving pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition
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 |
|---|---|---|
| Chondrofix Osteochondral AllograftAlso: ChondrofixAllogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone | Procedure or surgery | Chondrofix |
Primary outcome
KOOS Subscale
Time frame: 24 Months
The overall mean change from baseline to 24 months in the KOOS Pain and KOOS Function in Daily Living (ADL) subscale scores.
3 secondary outcomes
X-ray & MRI Evaluation
Time frame: Baseline and 1.5, 3, 6, 12, 24, & 60 months
IKDC Knee Examination
Time frame: Baseline & 1.5, 3, 6, 12, 24, & 60 months
Subject Reported Questionnaires
Time frame: Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months
Results and safety
The study was stopped early (reason given: Inadequate enrollment and decreased need for clinical data to support product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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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.
Nikesha N Harrington study chair
Zimmer Orthobiologics, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chondrofix Osteochondral Allograft in people with Articular Cartilage Disorder and Degeneration; Articular Cartilage, run by Zimmer Orthobiologics, Inc. at 5 sites in United States.
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 was stopped early (reason given: Inadequate enrollment and decreased need for clinical data to support product). Results are not available in the source record.
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?
KOOS Subscale (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2014.