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Investigation of a Customized Femoral Resurfacing Implant (Knee100)

This study is currently recruiting participants.
Verified February 2013 by Episurf Medical AB
Sponsor:
Information provided by (Responsible Party):
Episurf Medical AB
ClinicalTrials.gov Identifier:
NCT01690689
First received: August 10, 2012
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.


Condition Intervention
Focal Lesions of Articular Cartilage of Knee
 Device: Implant surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Episurf Medical AB:

Primary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Clinical performance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Clinical performance, by questionnaires and knee ROM measurements.


Estimated Enrollment: 26
Study Start Date: December 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery
Implant surgery
 Device: Implant surgery

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female
  2. Age 30 ≤ 65 years
  3. 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
  4. Cartilage lesion area < 3.2 cm2 (diameter < 2 cm)
  5. Failed earlier conservative or surgical interventions such as lavage, abrasions, drilling or microfracture
  6. VAS-pain symptom >40 for more than 6 months
  7. 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)
  8. Capable of completing self-administered questionnaires
  9. Willing to comply with the follow-up requirements of the study
  10. Signed informed consent

Exclusion Criteria:

  1. BMI ≥ 35 kg/m2 (severe obesity)
  2. Instability or deficiency of soft tissues, vascular or muscular insufficiency
  3. Metabolic disorders which may impair bone formation
  4. Diabetes mellitus
  5. Smokers
  6. 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)
  7. Irresolvable joint pain or loss-of-function with an undeterminable cause
  8. Diagnosis of a concomitant meniscal injury in involved knee that requires surgical intervention
  9. Loss of joint space on standing radiographs (≥ 1 on Ahlbäck-scale (0-5))
  10. Avascular necrosis
  11. Infections, systemic or local
  12. Known metal allergies
  13. History of inflammatory arthritis
  14. Pregnancy
  15. Pacemaker implant
  16. History of drug or substance abuse
  17. Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immune stimulating or immunosuppressive agents
  18. Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study.
  19. Condition that may have an impact on the outcome of the investigation as judged by the Investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690689

Contacts
Contact: Magnus Forssblad, MD, PhD magnus.forssblad@capio.se
Contact: Alexander Cristea, PhD alex@episurf.com

Locations
Sweden
Lund University Hospital, Department of Ortopedics Recruiting
Lund, Sweden
Contact: David Roberts, MD, PhD     +46(46) -17 10 00        
Capio Artro Clinic Recruiting
Stockholm, Sweden
Contact: Magnus Forssblad, MD, PhD     +46 (8)-406 27 00        
Sponsors and Collaborators
Episurf Medical AB
  More Information

No publications provided

Responsible Party: Episurf Medical AB
ClinicalTrials.gov Identifier: NCT01690689     History of Changes
Other Study ID Numbers: ALCR-120412-01
Study First Received: August 10, 2012
Last Updated: February 25, 2013
Health Authority: Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on May 23, 2013