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Investigation of a Customized Femoral Resurfacing Implant (Knee100)

Primary Purpose

Articular Cartilage Disorder

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Implant surgery

About this trial

This is an interventional treatment trial for Articular Cartilage Disorder

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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)
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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

Implant surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical performance

Clinical performance, by questionnaires and knee ROM measurements.

Full Information

NCT ID

NCT01690689

First Posted

August 10, 2012

Last Updated

December 14, 2020

Sponsor

Episurf Medical Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01690689

Brief Title

Investigation of a Customized Femoral Resurfacing Implant

Acronym

Knee100

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

March 31, 2017 (Actual)

Study Completion Date

March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Episurf Medical Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Articular Cartilage Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Experimental

Arm Description

Implant surgery

Intervention Type

Device

Intervention Name(s)

Implant surgery

Intervention Description

surgery

Primary Outcome Measure Information:

Title

Number of participants with Adverse Events

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Clinical performance

Description

Clinical performance, by questionnaires and knee ROM measurements.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick Zetterberg

Organizational Affiliation

Episurf Medical

Official's Role

Study Director

Facility Information:

Facility Name

Lund University Hospital, Department of Ortopedics

City

Lund

Country

Sweden

Facility Name

Aleris Specialistvård

City

Stockholm

Country

Sweden

Facility Name

Sports Medicine Umeå

City

Umeå

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Investigation of a Customized Femoral Resurfacing Implant

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