Investigation of a Customized Femoral Resurfacing Implant (Knee100)

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.

Study Overview

• Status: Completed
• Conditions: Articular Cartilage Disorder
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Lund University Hospital, Department of Ortopedics
  • Stockholm, Sweden
    • Aleris Specialistvård
  • Umeå, Sweden
    • Sports Medicine Umeå

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery; Implant surgery	Device: Implant surgery; surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance	Clinical performance, by questionnaires and knee ROM measurements.	24 months

Collaborators and Investigators

• Sponsor: Episurf Medical Inc.
• Investigators: Study Director: Frederick Zetterberg, Episurf Medical

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: ALCR-120412-01