Investigation of a Customized Femoral Resurfacing Implant

NCT01690689 | Completed DMC

• 1 other identifier: ALCR-120412-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Articular Cartilage Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical performance

  24 months

Study Arms (1)

Surgery

EXPERIMENTAL

Implant surgery

Device: Implant surgery

Interventions

Implant surgery DEVICE

surgery

Surgery

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Episurf Medical Inc.: lead

Study Sites (3)

Lund University Hospital, Department of Ortopedics

Lund, Sweden

Location

Aleris Specialistvård

Stockholm, Sweden

Location

Sports Medicine Umeå

Umeå, Sweden

Location

Study Officials

• Frederick Zetterberg

  Episurf Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: September 24, 2012
• Study Start: December 1, 2012
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

SE (3)