Episealer® Knee System IDE Clinical Study
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04000659 |
|
Recruitment Status :
Recruiting
First Posted : June 27, 2019
Last Update Posted : May 5, 2022
|
Sponsor:
Episurf Medical Inc.
Collaborator:
MCRA, LLC
Information provided by (Responsible Party):
Episurf Medical Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Degenerative Lesion of Articular Cartilage of Knee | Device: Episealer Knee System Procedure: Microfracture | Not Applicable |
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Episealer Knee System (Episealer Trochlea Solo, Episealer Femoral Twin, and Episealer Condyle Solo) compared to microfracture (with or without debridement) in a group of subjects that require repair of up to 2 focal femoral chondral or osteochondral lesions in the knee.
Clinical success will be analyzed via subject reported outcomes to measure function and pain improvements as compared to baseline, incidence of secondary surgical interventions for the treated knee, absence of subsidence or migration through radiographic assessment, and assessment of weight-bearing status.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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. |
| Masking: | Single (Participant) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer® Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions |
| Actual Study Start Date : | June 18, 2020 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | June 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Episealer Knee System
The experimental arm will comprise of subjects that will be treated with the Episealer Knee System.
|
Device: Episealer Knee System
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. |
|
Placebo Comparator: Microfracture
The control arm will comprise of subjects that will receive a Microfracture surgery.
|
Procedure: Microfracture
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. |
Primary Outcome Measures :
- Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores [ Time Frame: 24 Months ]This endpoint will examine the change in KOOS subscores at 24 months
- Change in Visual Analog Scale (VAS) Pain Scores [ Time Frame: 24 Months ]This endpoint will examine the change in VAS Pain scores at 24 months
- Incidence of Secondary Surgical Intervention [ Time Frame: 24 Months ]This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months
- Incidence of subsidence or migration at 24 months [ Time Frame: 24 Months ]This endpoint will examine the incidence of subsidence/migration at 24 months
- Weight bearing status [ Time Frame: 8 weeks ]This endpoint will examine the weight bearing status at 8 weeks
Secondary Outcome Measures :
- Change in the KOOS Subscores at all follow-up time points [ Time Frame: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months ]This endpoint will examine the change in KOOS subscores at all follow-up time points
- Change in VAS Pain score at all follow-up time points [ Time Frame: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months ]This endpoint will examine the change in VAS Pain scores at all follow-up time points
- Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points [ Time Frame: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months ]This endpoint will examine the change in SF-12 scores at all follow-up time points
- Incidence of radiographic findings at all follow-up time points [ Time Frame: 8 weeks, 12-months, and 24-months ]This endpoint will examine the incidence of radiographic findings at all follow-up time points
- Incidence of adverse events and device deficiencies at all follow-up time points [ Time Frame: 3-weeks, 8-weeks, 6-months, 12-months and 24-months ]This endpoint will examine the safety via the incidence of adverse events and device deficiencies at all follow-up time points
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
- Age between 30 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
- Have undergone prior non-surgical management in the index knee
EXCLUSION CRITERIA:
- Have a BMI greater than 35 kg/m2
- Have undergone prior surgical treatment for the cartilage defect
- Have an existing knee prosthesis in the index knee
- Have a bone disease that impacts bone quality
- Have rheumatoid arthritis
- Have a known immunodeficiency
- Have known allergies to Cobalt-Chrome alloy or Titanium
- Have any contraindication to MRI
- Any condition, therapy or medication that would interfere with healing or the evaluation of outcome measures
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000659
Contacts
| Contact: Katarina Flodström | 1 686 845 9447 | Katarina.Flodstrom@episurf.com |
Locations
| United States, Arizona | |
| Physicians Research Group | Recruiting |
| Tempe, Arizona, United States, 85284 | |
| Contact: Vianeth Santiago 480-868-7014 v.santiago@prgresearch.com | |
| Contact: Tammy Fuentes 800-774-1534 t.fuentes@prgresearch.com | |
| Principal Investigator: Eric Eifler, MD | |
| United States, California | |
| Horizon Clinical Research | Recruiting |
| La Mesa, California, United States, 91942 | |
| Contact: Dino Subasic, BS 619-456-6012 dino@horizontrials.com | |
| Principal Investigator: Scott Hacker, MD | |
| United States, Louisiana | |
| Ochsner Sports Medicine Institute | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: John Maggio 504-842-0263 jmaggio@ochsner.org | |
| Contact: Graylin Jacobs (504) 842-0263 Graylin.jacobs@ochsner.org | |
| Principal Investigator: Deryk Jones, MD | |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Rose Williams 551-996-4261 Rose.Williams@hackensackmeridian.org | |
| Principal Investigator: Yair Kissin, MD | |
| United States, New York | |
| Plancher Orthopaedics & Sports Medicine | Recruiting |
| New York, New York, United States, 10128 | |
| Contact: Stephanie Petterson 203-869-2002 spetterson@ofals.org | |
| Principal Investigator: Kevin Plancher, MD | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43202 | |
| Contact: Jenna DeFranco, BS 614-293-2761 Jenna.DeFranco@osumc.edu | |
| Principal Investigator: David Flanigan, MD | |
| United States, Tennessee | |
| Clinical Research Solutions | Recruiting |
| Jackson, Tennessee, United States, 38305 | |
| Contact: Brittany Reyes, BS 731-613-8248 breyes@crssites.com | |
| Principal Investigator: Jason Hutchison, MD | |
| Denmark | |
| Idrætsklinikken, Aarhus Universitetshospital | Recruiting |
| Aarhus N, Denmark, 8200 | |
| Contact: Torsten Grønbech Nielsen +45 40491184 torsten.gronbech.nielsen@auh.rm.dk | |
| Principal Investigator: Martin Lind, MD | |
| Germany | |
| Universitatsmedizin Berlin Charite | Recruiting |
| Berlin, Germany, 10117 | |
| Contact: Derya Belkacem 030/450 615 196 derya.belkacem@charite.de | |
| Contact: Anne Zergiebel 030/450 515 235 anne.zergiebel@charite.de | |
| Principal Investigator: Tobias Jung, MD | |
| Orthocentrum Hamburg | Recruiting |
| Hamburg, Germany, 20149 | |
| Contact: Rene Kaiser +4940443639 kaiser@oc-h.de | |
| Principal Investigator: Johannes Holz, MD | |
| United Kingdom | |
| University Hospital Coventry and Warwickshire NHS Trust | Recruiting |
| Coventry, England, United Kingdom, CV2 2DX | |
| Contact: Kerri McGowan kerri.mcgowan@uhcw.nhs.uk | |
| Principal Investigator: Feisal Shah, MD | |
| University Hospital Southampton NHS Foundation Trust | Recruiting |
| Southampton, So16 6yd, United Kingdom | |
| Contact: Michelle Beveridge +442381208141 michelle.beveridge@uhs.nhs.uk | |
| Principal Investigator: Mark Frame, MD | |
| Royal Orthopaedic Hospital | Recruiting |
| Birmingham, United Kingdom, B31 2AP - UK | |
| Contact: Claudette Jones, RN claudette.jones@nhs.net | |
| Principal Investigator: Tanweer Ashraf, MD | |
| Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust (RJAH) | Recruiting |
| Oswestry, United Kingdom, Shropshire SY10 7AG | |
| Contact: Jean Denton jeandenton@nhs.net | |
| Principal Investigator: Paul Jermin, MD | |
Sponsors and Collaborators
Episurf Medical Inc.
MCRA, LLC
Investigators
| Study Director: | Katarina Flodström | Episurf Medical Inc. |
| Responsible Party: | Episurf Medical Inc. |
| ClinicalTrials.gov Identifier: | NCT04000659 |
| Other Study ID Numbers: |
IDE 1006 |
| First Posted: | June 27, 2019 Key Record Dates |
| Last Update Posted: | May 5, 2022 |
| Last Verified: | April 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Keywords provided by Episurf Medical Inc.:
|
Knee Cartilage |