Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04808700
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 95
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Lesions in the cartilage are common disorders. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.

Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion.

In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing)

Condition or Disease	Intervention/Treatment	Phase
Focal Cartilage Lesions	Other: Follow-up of Episealer implant	N/A

Detailed Description

Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the medial femoral condyle. The quality of life of patients with focal cartilage defects is significantly affected and it has been shown that the quality of life is affected to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.

Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. The implant and surgical instruments are customized to each patient's joint anatomy, position, and size of injury, based on patient-specific images (MRI).

In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
• Actual Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Focal cartilage lesion Patients with focal cartilage lesions who underwent a knee surgery using the Episealer implant	Other: Follow-up of Episealer implant; Follow-up and radiographic evaluation in patients who received an Episealer implant

Outcome Measures

Primary Outcome Measures

1. Radiographic and clinical evaluation [within a time frame of 2 years]

   Survival of the implant up to 24 months post treatment with loss of the primary implant

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible

• Minimal age of 18 years old (Preferred age group >40 years)

• Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion. The maximum size of the lesion is set at 6cm².

• Informed consent obtained

Exclusion Criteria:

• Active or recent (<1 yr) septic arthritis of the involved knee

• Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee

• (Severe) osteoarthritis in the involved or other compartments of the involved knee

• Severe osteoporosis

• MRI not possible (eg. due to pacemaker)

• Marked valgus- or varus alignment (>6 degrees)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT04808700
• Other Study ID Numbers: S57685
• First Posted: Mar 22, 2021
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitaire Ziekenhuizen Leuven: Cartilage lesions; Episealer implant

Study Results

No Results Posted as of Mar 22, 2021