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ID
Source
Brief title
Health condition
meniscal injury and cartilage loosening.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the dGEMRIC index (T1gd, in ms) at one year follow-up of the treated region
Secondary outcome
- T1gd (ms) at healthy regions surrounding the treated area will be measured for reference
- Patient reported outcome of knee function, quality of life and pain will be collected preoperatively, and at 3, 6 and 12 months
Background summary
Rationale: Coblation treatment of degenerative cartilage in the knee is a safe alternative to mechanical debridement, with possible advantages that it creates a smoother cartilage surface and that patient reported outcome is better. However, the in vivo effect of coblation treatment on knee cartilage quality has no been studied.
Objective: The primary objective is to study the in vivo effect of coblation treatment on knee cartilage quality in patients with meniscal injury and cartilage loosening of the knee. The secondary objective is to study the relationship between knee cartilage quality after coblation treatment, and patient reported outcome and patient characteristics.
Study design: A cohort study, with follow-up up till one year after surgery.
Study population: Patients aged 18y and up, who are scheduled for arthroscopic treatment, in our hospital, for meniscal injury and cartilage loosening.
Intervention: During arthroscopy of the knee, coblation treatment uses radiofrequency energy to break molecular bonds to dissolve soft tissue at low relative temperatures.
Main study parameters/endpoints: The primary outcome is the dGEMRIC index (T1gd, in ms) at one year follow-up of the treated region. dGEMRIC can be used to assess the concentration of glycosamino-glycans (GAGs) in the extracellular cartilage matrix.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The benefits for the subjects are that, according to the current literature, coblation treatment results in better patient reported outcome when up till 10 years when compared to mechanical debridement. The extra time subjects have to invest in the study is about 3 hours over a year, with one extra visit to the hospital. No extra risks are expected. Both coblation treatment and dGEMRIC are safe procedures and the burden of the PROMS are low.
Study objective
It is expected that coblation treatment has an effect on knee cartilage quality in patients with meniscal lesions and cartilage loosening of the knee
Study design
Preoperative, follow-up at 3 months, 6 months , and at 1 year
Intervention
Coblation treatment during knee arthroscopy
Inclusion criteria
- focal cartilage lesions, ICRS grade 2-3a (i.e. partial thickness) (Brittberg and Peterson, 1998)
- age ≥18y
Exclusion criteria
- subjects with general contraindications for MRI scanning
- a known allergic reaction to gadolinium-containing contrast agents
- renal insufficiency (glomerular filtration rate, <60 mL/min)
- Subjects who do not understand Dutch written language, necessary for completing the PROMS
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7597 |
| Other | CME LUMC : P18.157 |