Articular Cartilage DisorderKnee100NCT01690689
Investigation of a Customized Femoral Resurfacing Implant
A study testing Implant surgery in people with Articular Cartilage Disorder, run by Episurf Medical Inc. at 3 sites in Sweden.
Trial summary
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Articular Cartilage Disorder
- What is being tested?
- Implant surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesSweden
- Study dates
- Dec 2012to 31 Mar 2017
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age 30 ≤ 65 years
- Chondral defects of the femoral cartilage ICRS grade 3 (severely abnormal cartilage defects > 50% of the cartilage depth) or grade 4 (severely abnormal, through the cartilage depth) on medial or lateral femoral condyles
- Cartilage lesion area < 3.2 cm2 (diameter < 2 cm)
- Failed earlier conservative or surgical interventions such as lavage, abrasions, drilling or microfracture
- VAS-pain symptom >40 for more than 6 months
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- The arthroscopic finding corresponds to the expected; size of cartilage lesion is correct and no other significant pathology (see CIP, "Intra-operative check-list", Appendix I)
- Capable of completing self-administered questionnaires
- Willing to comply with the follow-up requirements of the study
- Signed informed consent
Who cannot join
- BMI ≥ 35 kg/m2 (severe obesity)
- Instability or deficiency of soft tissues, vascular or muscular insufficiency
- Metabolic disorders which may impair bone formation
- Diabetes mellitus
- Smokers
- Diagnosis of a concomitant knee injury which the Investigator appreciates may interfere with study participation (i.e. may confound efficacy assessment or healing at the involved knee joint level)
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- Irresolvable joint pain or loss-of-function with an undeterminable cause
- Diagnosis of a concomitant meniscal injury in involved knee that requires surgical intervention
- Loss of joint space on standing radiographs (≥ 1 on Ahlbäck-scale (0-5))
- Avascular necrosis
- Infections, systemic or local
- Known metal allergies
- History of inflammatory arthritis
- Pregnancy
- Pacemaker implant
- History of drug or substance abuse
- Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immune stimulating or immunosuppressive agents
- Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study.
- Condition that may have an impact on the outcome of the investigation as judged by the Investigator.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Lund University Hospital, Department of Ortopedics
Lund
Aleris Specialistvård
Stockholm
Sports Medicine Umeå
Umeå
About this study
Official title: Investigation of a Customized Femoral Resurfacing Implant (Episealer® Knee Condyle Device) to Assess the Safety Profile and Performance for 2 Years Post-operatively
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
Read the detailed description
The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.
- Conditions
- Articular Cartilage Disorder
- Being tested
- Implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant surgeryDevice
surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Implant surgery Receives: Device: Implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05
Measured: 24 months
Secondary outcomes (1)
Clinical performance
Clinical performance, by questionnaires and knee ROM measurements.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startDec 2012
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Episurf Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Zetterberg, Study director, Episurf Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690689
- Sponsor's protocol ID
- ALCR-120412-01
- Acronym
- Knee100
- Status last verified
- Dec 2020
- First submitted
- 10 Aug 2012
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Customized Femoral Resurfacing Implant (Episealer® Knee Condyle Device) to Assess the Safety Profile and Performance for 2 Years Post-operatively
- ClinicalTrials.gov ID
- NCT01690689
- Acronym / sponsor ID
- Knee100 / ALCR-120412-01
- Conditions
- Articular Cartilage Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Episurf Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 24 Sep 2012 (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 purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
Detailed description
The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Device: Implant surgeryImplant surgery |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- Age 30 ≤ 65 years
- Chondral defects of the femoral cartilage ICRS grade 3 (severely abnormal cartilage defects > 50% of the cartilage depth) or grade 4 (severely abnormal, through the cartilage depth) on medial or lateral femoral condyles
- Cartilage lesion area < 3.2 cm2 (diameter < 2 cm)
- Failed earlier conservative or surgical interventions such as lavage, abrasions, drilling or microfracture
Key exclusion criteria (19 listed)
- BMI ≥ 35 kg/m2 (severe obesity)
- Instability or deficiency of soft tissues, vascular or muscular insufficiency
- Metabolic disorders which may impair bone formation
- Diabetes mellitus
- Smokers
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 |
|---|---|---|
| Implant surgerysurgery | Device | Surgery |
Primary outcome
Number of participants with Adverse Events
Time frame: 24 months
The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05
1 secondary outcome
Clinical performance
Time frame: 24 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 17 Dec 2020.
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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.
Frederick Zetterberg study director
Episurf Medical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant surgery in people with Articular Cartilage Disorder, run by Episurf Medical Inc. at 3 sites in Sweden.
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 10 inclusion and 19 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Number of participants with Adverse Events (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 17 Dec 2020.