Bone Marrow Lesion of the knee joint S72.41 S82.18 M17.1
Conditions
Interventions
Group 1: This study is a literature-controlled, consecutive prospective case series evaluating the adjunctive filling of bone marrow lesions with CERAMENT BONE VOID FILLER in patients treated with abr
Sponsors
Abteilung für Unfallchirurgie und Orthopädie, Kliniken Landkreis Diepholz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients capable of giving informed consent Bone marrow lesion diagnosed on MRI (poorly defined areas with increased signal intensity in the normal subchondral and epiphyseal bone marrow on fat-suppressed, fluid-sensitive FSE sequences) Osteoarthritis grade 1–3 according to the Kellgren–Lawrence score on the preoperative X-ray AND arthroscopically (intraoperatively) ICRS grade 1–3 Less invasive treatments (e.g., corticosteroid or hyaluronic acid injections, physiotherapy) have been unsuccessful
Exclusion criteria
Exclusion criteria: Patients who are not capable of giving informed consent Patients with an acute traumatic bone marrow lesion Suspected infection Patients with Kellgren–Lawrence grade 0 or 4 Patients with ICRS grade 0 or 4 Patients with a contraindication to the use of CERAMENT BONE VOID FILLER (hypersensitivity to iohexol or any of the other components; local infection at the implantation site; pregnancy / breastfeeding; manifest thyrotoxicosis) as well as patients with pre-existing calcium metabolism disorders Simultaneous participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported pain (12 months vs. baseline): Pain is assessed using the Visual Analog Scale (VAS) preoperatively and during follow-up examinations (postoperative day 2, 3 months, 6 months, 12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee joint functionality – 12 months vs. baseline: The International Knee Documentation Committee Score (IKDC-2000) is recorded preoperatively and during follow-up examinations. Complication rate: Extravasation of bone graft substitute material into the joint (including any potential consequences), revision rate, wound-healing disorders, and comparison with the literature. Prosthesis rate: Conversion rate to endoprosthetic treatment within 12 months and comparison with the literature. Radiological consolidation of the bone marrow lesion – 12 months vs. baseline: Progress of consolidation of the bone marrow lesion on MRI, determined using an irregular area calculator software. | — |
Countries
Germany
Contacts
Public ContactJens Peters
Abteilung für Unfallchirurgie und Orthopädie, Kliniken Landkreis Diepholz
Outcome results
None listed