Episealer® Knee System IDE Clinical Study

NCT04000659 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IDE 1006
• Study Type: interventional
• Target: 13
• Locations: 4 countries
• Sites: 13

Brief Summary

The study is a randomized, prospective, multicenter, controlled clinical trial of the Episealer Knee System. The Episealer Knee System is intended for subjects with up to two focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment.

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Keywords

Knee; Cartilage

Outcome Measures

Primary Outcomes (5)

• Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores

  This endpoint will examine the change in KOOS subscores at 24 months

  24 Months

• Change in Visual Analog Scale (VAS) Pain Scores

  This endpoint will examine the change in VAS Pain scores at 24 months

  24 Months

• Incidence of Secondary Surgical Intervention

  This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months

  24 Months

• Incidence of subsidence or migration at 24 months

  This endpoint will examine the incidence of subsidence/migration at 24 months

  24 Months

• Weight bearing status

  This endpoint will examine the weight bearing status at 8 weeks

  8 weeks

Secondary Outcomes (5)

• Change in the KOOS Subscores at all follow-up time points

  3-weeks, 8-weeks, 6-months, 12-months, and 24-months

• Change in VAS Pain score at all follow-up time points

  3-weeks, 8-weeks, 6-months, 12-months, and 24-months

• Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points

  3-weeks, 8-weeks, 6-months, 12-months, and 24-months

• Incidence of radiographic findings at all follow-up time points

  8 weeks, 12-months, and 24-months

• Incidence of adverse events and device deficiencies at all follow-up time points

  3-weeks, 8-weeks, 6-months, 12-months and 24-months

Study Arms (2)

Episealer Knee System

EXPERIMENTAL

The experimental arm will comprise of subjects that will be treated with the Episealer Knee System.

Device: Episealer Knee System

Microfracture

PLACEBO COMPARATOR

The control arm will comprise of subjects that will receive a Microfracture surgery.

Procedure: Microfracture

Interventions

Episealer Knee System DEVICE

The Episealer Knee System is comprised of individualized endoprosthetic resurfacing implants and implantation tools (Episealer Toolkit). The implants are designed to replace the articulating surface which has been damaged due to femoral knee chondral and osteochondral defects.

Episealer Knee System

Microfracture PROCEDURE

Microfracture is a minimally invasive surgical technique developed to repair defects in articular cartilage and reduce pain in the knee joint. Microfracture techniques are described in the orthopedic literature and are performed arthroscopically.

Microfracture

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥ 30 years and ≤ 70 years.
• Have up to 2 symptomatic femoral chondral or osteochondral defects in the index knee on the medial or lateral femoral condyles or the knee trochlea area, which are:
• ICRS Grade 2, 3 or Grade 4
• Each suitable for treatment with 1 Episealer device NOTE: Additional femoral cartilage lesions which, in the opinion of the investigator, are asymptomatic and free from underlying bone lesions (e.g., bone edema) will not be treated.
• Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2.
• Subjects with up to two defects ≥ 1.5 cm2 and ≤ 4.0 cm2, that are surrounded by adequate circumferential cartilage as determined by the investigator, will be randomized.
• Subjects with at least one defect \> 4.0 cm2 and ≤ 7.0 cm2, with adequate bony support as determined by the investigator, will not be randomized, and will receive the Episealer device.
• Have screening scores that meet the following criteria:
• Visual Analog Scale (VAS) pain score of the index knee of ≥ 40 mm
• KOOS Overall Score of ≤ 60
• Have experienced knee pain symptoms and undergone prior non-surgical management (e.g., physical therapy, bracing, HA injections) for at least 4 weeks prior to being considered for the study.
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
• Be willing and able to comply with all study procedures including all pre-operative, post-operative, and rehabilitation requirements.
• If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant in the next 24 months.

You may not qualify if:

• Subjects who meet any of the following pre-operative screening criteria will be excluded from participation in this study:
• Have a Body Mass Index (BMI) greater than 37 kg/m2.
• Have an ICRS Grade 3 or 4 tibial lesion of any size, or an ICRS Grade 4 patella lesion/fissure ≥ 2.0 mm in width in the index knee.
• Have malalignment of \>8 degrees varus or valgus in the index knee based on standard AP x-rays.
• Have deficits in flexion or extension of \>10 degrees in the index knee as compared to the contralateral knee.
• Have an existing prosthesis in the index knee compartment or opposing joint surface.
• Have joint instability in the index knee due to soft tissue or muscular insufficiency.
• Have inadequate bone stock underlying the lesion site, in the opinion of the investigator.
• Have any condition, therapy, or medication that may impair bone healing or prevent adequate implant fixation (e.g., osteoporosis).
• Have a diagnosis of a concomitant knee injury, which in the opinion of the investigator, may confound assessment of the index knee.
• Have any meniscus tears or defects that require resection of more than 1/3 of the meniscus in the compartment to be treated (i.e., medial meniscus when medial femoral compartment is being treated; lateral meniscus when lateral femoral compartment is being treated).
• Have a contralateral knee with symptomatic cartilage, meniscal, or ligamentous lesions; generalized osteoarthritis, or any condition that requires surgery, which in the opinion of the investigator, may confound assessment of the index knee, or any condition that requires surgery.
• Have any condition that is unrelated to the index knee and significantly impairs walking ability (e.g., spinal stenosis, sciatica).
• Have undergone previous treatment with autograft or allograft transfer, synthetic plugs, or microfracture in the index knee within 6 months of screening. (NOTE: Subjects who have undergone debridement at any point in the past are not excluded).
• Have a loss of joint space on standing radiographs (Kellgren-Lawrence Grade ≥3) in the index knee.

Sponsors & Collaborators

• Episurf Medical Inc.: lead
• MCRA: collaborator

Study Sites (13)

Physicians Research Group

Tempe, Arizona, 85284, United States

Location

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Plancher Orthopaedics & Sports Medicine

New York, New York, 10128, United States

Location

Ohio State University

Columbus, Ohio, 43202, United States

Location

Helios Clinical Research

Jackson, Tennessee, 38305, United States

Location

North Texas Medical Research Institute

Dallas, Texas, 75254, United States

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 2E1, Canada

Location

Universitatsmedizin Berlin Charite

Berlin, 10117, Germany

Location

Orthocentrum Hamburg

Hamburg, 20149, Germany

Location

University Hospital Coventry and Warwickshire NHS Trust

Coventry, England, CV2 2DX, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Katarina Flodström

  Episurf Medical Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this investigation, neither the investigator nor the subject can be blinded to the treatment group assignment due to the implant's distinctive form that can be detected on radiographs; however, the randomization assignment will not be disclosed to the subject until after surgery is performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 180 subjects will be enrolled and randomized using a 2:1 ratio (Episealer: Microfracture). Within each site, subjects will be randomized into one of the two study arms using a blocked randomization scheme with varying block sizes.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 27, 2019
• Study Start: June 18, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

GB (2); US (8); DE (2); CA (1)