The effect of coblation treatment on knee cartilage quality in patients with meniscal lesions and cartilage loosening of the knee

The effect of coblation treatment on knee cartilage quality in patients with meniscal lesions and cartilage loosening of the knee - Coblation study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52659

Enrollment

Registered

2019-01-21

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

meniscal injury and cartilage loosening

Interventions

Radiofrequency energy is applied using the Werewolf Coblation system (Smith & Nephew Inc., Cordova, TN, USA). The WEREWOLF System and FLOW 50 Wand using Lo mode is FDA-cleared for chondroplasty and

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - focal cartilage lesions, ICRS grade 2-3a (i.e. partial thickness) - meniscal laesions - age between 18y and 65y

Exclusion criteria

Exclusion criteria: - Subjects who do not understand Dutch written language, necessary for completing the PROMS - Systemic or autoimmune disease (e.g. RA) - Clinical signs of polyathrosis - Posttraumatic functional disabilities

Design outcomes

Primary

Measure	Time frame
The Outerbridge cartilage lesion grading score at one-year follow-up of the treatment region.	—

Secondary

Measure	Time frame
• The quantifiable Na18F-PET/CT tracer uptake in Standardized Uptake Values (SUV) and target to background ratio (TBR). (Jonnakuti et al. 2018) • Patient reported outcome of knee function, quality of life and pain will be collected preoperatively, and at 3, 6 and 12 months • Cartilage thickness in mm of the treatment region	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)