Subchondroplasty Procedure in Patients With Bone Marrow Lesions
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|ClinicalTrials.gov Identifier: NCT03430219|
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment|
|Bone Marrow Lesions Bone Marrow Edema||Device: Subchondroplasty Procedure|
Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure will be invited to participate. This study will enroll up to 250 patients across 10 investigative centers in Europe over a period of 12 months. The maximum study duration is expected to be 6 years.
Follow-up assessments will be conducted at 1 month, 3, 6, 12-months and annually up to 5 years post injection; and subjects will be asked questions regarding their pain and functioning to further understand long-term outcomes.
For a subset of approximately 100 consecutive subjects at selected centers, a long standing X-ray and MRI at screening and 12 months will be obtained.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||March 1, 2024|
The SCP Procedure targets and fills bone defects with AccuFill bone substitute material utilizing an arthroscopic / percutaneous approach
Device: Subchondroplasty Procedure
AccuFill is an injectable, self-setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure
Other Name: AccuFill Injectable Calcium Phosphate
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale [ Time Frame: 12 months ]Change in pain following SCP Procedure as measured by the KOOS pain subscale. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 5 year ]Change in KOOS pain and function subscales and overall scores. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale.
- Numerical Rating Scale (NRS) pain scale [ Time Frame: 5 year ]Change in pain as measured by NRS pain scale. The NRS is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last week
- EuroQol-5 Dimensions (EQ-5D) [ Time Frame: 5 year ]
Change in quality of life as measured by EQ-5D. The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-5L descriptive component assesses five dimensions:
mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over five levels of severity
- Heath care utilization Questionnaire [ Time Frame: 5 year ]Healthcare utilization for each subject will be recorded via a not validated questionnaire to capture information about any treatments, therapies, specialists, etc. utilized for pain or symptom relief following study treatment and follow-up.
- Subject global satisfaction Questionnaire [ Time Frame: 5 year ]The subject global satisfaction is concerned with determining patient-related factors such as patients' satisfaction with treatment, and experienced health outcomes. The questionnaire uses a not validated 11 point scale anchored by 0 "totally dissatisfied" and 10 "extremely satisfied".
- Occurrence of Re-operations [ Time Frame: 5 year ]Occurrence of subjects that require any re-operation on the index knee from initial SCP Procedure.
- Time to Re-operations [ Time Frame: 5 year ]Time from initial SCP Procedure to any re-operation
- Occurrence of Revisions [ Time Frame: 5 year ]Occurrence of subjects that require revision on the index knee from initial SCP Procedure.
- Time to Revisions [ Time Frame: 5 year ]Time from initial SCP Procedure to revisions
- X-ray [ Time Frame: 12 months ]X-ray evaluation of alignment, joint space narrowing, osteophyte and cyst formation and subchondral sclerosis
- MRI BML lesion size [ Time Frame: 12 months ]MRI evaluation of Bone Marrow Lesion Size
- MRI BML type [ Time Frame: 12 months ]MRI evaluation of Bone Marrow Lesion Type
- MRI Intraosseous vascularity [ Time Frame: 12 months ]MRI evaluation of Intraosseous Vascularity
- MRI location of injectate [ Time Frame: 12 months ]MRI evaluation of Location of Injectate.
- Adverse Events [ Time Frame: 5 year ]Occurrence of Adverse Events
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): NCT03430219
|Contact: Linda Korthoutemail@example.com|
|Contact: Cahit Akbasfirstname.lastname@example.org|
|Contact: Peter Angele, MD|
|Istituto Clinico Humanitas||Recruiting|
|Rozzano (MI), Italy|
|Contact: Elizaveta Kon, MD|
|Contact: Pieter Emans, MD|
|Hospital Universitari Vall d´Hebron||Recruiting|
|Contact: Joan Minguell, MD|
|Principal Investigator:||Peter Angele, Prof.Dr.med||University of Regensburg|