NL-OMON52931
Completed
Not Applicable
Prospective Post-Market Data Collection on Patients with Bone Marrow Lesions in the Knee Treated with Subchondroplasty procedure - SCP-EMEA-01
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone marrow lesion | Bone defect
- Sponsor
- Zimmer Biomet
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- At least 18 years of age at time of screening
- •\- Patient with BML(s) in one or both knees, as diagnosed by the treating
- •physician, willing and eligible to undergo the SCP procedure
- •\- One or more BML(s) of the tibial plateau and/or femoral condyle extending to
- •the ar\-ticular surface of the joint confirmed on T2 weighted fat\-suppressed or
- •Proton Density MR Imaging by presence of white signal
- •\- Index knee alignment is defined radiographically as one of the following:
- •Neutral, \<\= 6° mechanical varus, or \<\= 6° mechanical valgus
- •\- A KOOS Pain subscale total score \< 70
- •\- Is refractory to conservative non\-surgical management of BML:
Exclusion Criteria
- •\- Existing acute or chronic infections at the surgical site
- •\- Bone in the index knee is non\-viable or not capable of supporting and
- •anchoring the implant
- •\- Known systemic disorders or any systemic inflammatory condition ( e.g.
- •rheumatoid arthritis)
- •\- Acute traumatic injuries with open wounds close to the bone defect which are
- •likely to become infected
- •\- Known metabolic bone disease, including disorders in calcium metabolism
- •\- Known immunologic abnormalities, including inflammatory bone disease
- •\- Has a history of any invasive malignancy (except non\-melanoma skin cancer),
Outcomes
Primary Outcomes
Not specified
Similar Trials
Terminated
Not Applicable
A prospective audit of sentinel node biopsy for vulval carcinoma in Australia and New ZealandVulval carcinomaCancer - Other cancer typesACTRN12616000645459niversity Of Otago Christchurch316
Enrolling By Invitation
Not Applicable
Prospective data acquisition of patients presenting in the specialised CRPS outpatient clinic of the Unfallkrankenhaus Berlin for the assessment of the Budapest criteriaG90Disorders of autonomic nervous systemDRKS00020352Klinik für Unfallchirurgie, Universitätsmedizin Greifswald100
Recruiting
Phase 4
Post-Market Clinical Data Analysis With Skanrays Defibrillators (Clinical study to record the safety and performance data of Skanrays Defibrillators in real world scenario)CTRI/2023/05/053279Skanray Technologies Limited
Completed
Phase 4
A prospective study using the KerraCel™ dressing on multiple wound typesOncological wounds (e.g. radiation burns, cancerous wounds and surgical wounds once the cancerous tissue has been removed), traumatic wounds (e.g. abrasions and lacerations), cavity wounds (such as abdominal or thoracic) and wounds created from skin donor sitesInjury, Occupational Diseases, PoisoningISRCTN33932204KCI (United States)48
Completed
Not Applicable
Subchondroplasty Procedure in Patients With Bone Marrow LesionsBone Marrow LesionsBone Marrow EdemaNCT03430219Zimmer Biomet93