Interventional procedure consultation document

Arthroscopic radiofrequency chondroplasty for discrete chondral defects of the knee

The cartilage over the ends of bones in the knee joint (articular cartilage) can be damaged by trauma, resulting in isolated (discrete) defects. Radiofrequency chondroplasty aims to reduce further damage by using heat to smooth and contour the rough edges of a defect.

The National Institute for Health and Care Excellence (NICE) is examining arthroscopic radiofrequency chondroplasty for discrete chondral defects of the knee and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about arthroscopic radiofrequency chondroplasty for discrete chondral defects of the knee.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 19 December 2013

Target date for publication of guidance: March 2014

 

 

 

 

1                      Provisional recommendations

1.1                  Evidence on the efficacy of arthroscopic radiofrequency chondroplasty for discrete chondral defects of the knee is limited but shows benefit in the short term, and there are no major safety concerns. Therefore this procedure may be used with normal arrangements for clinical governance, consent and audit.

1.2                  The procedure should only be carried out by clinicians with specific training in the use of arthroscopic radiofrequency ablation and with particular attention to the avoidance of thermal injury.

1.3                  Further research into arthroscopic radiofrequency chondroplasty of the knee should clearly document patient selection and the types of chondral defects being treated. More evidence on long-term outcomes would be useful.

 

 

 

2                      Indications and current treatments

2.1                  Discrete chondral defects usually occur in articular cartilage as a result of trauma. The rough, irregular edges of a defect may cause inflammation, swelling, pain and difficulty walking. Progressive degeneration of a chondral defect can lead to exposure of the underlying bone and result in arthritis. If pieces of cartilage break off from the edges of a defect they may lead to cartilage damage elsewhere in the knee, with subsequent arthritic changes.

2.2                  Treatment options depend on the size and site of the chondral defect. The condition is usually chronic, and different treatment strategies may be needed at different stages. Conservative treatments include analgesics, corticosteroid injections and hyaluronic acid injections to relieve pain and inflammation. Physiotherapy and/or prescribed exercise may also be used to improve knee function and mobility.

 

 

 

 

3                      The procedure

3.1                  Radiofrequency chondroplasty aims to slow the progression of discrete chondral defects by removing the unstable edges of the defect, producing a smooth, stable articular cartilage surface.

3.2                  The procedure is usually done with the patient under general anaesthesia. An arthroscope is inserted into the knee and large chondral defects are trimmed from the weight-bearing surfaces of the femoral condyles, using instruments such as a blunt hook or electric shaver. Under arthroscopic guidance, a radiofrequency probe is then used to smooth the edge of the cartilage defect with irrigation to stabilise temperature and flush any debris. The aim is to improve mechanical stability and prevent further progression of cartilage damage.

 

 

 

4                      Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview [add URL].

4.1                  A randomised controlled trial of 60 patients treated by bipolar radiofrequency energy (n=30) or mechanical shaver debridement (n=30) reported that patients in the bipolar radiofrequency energy group returned to work sooner than patients in the mechanical shaver debridement group (16.4±6.5 days compared with 21.7±6.1 days, p=0.002).

4.2                  In the randomised controlled trial of 60 patients treated by bipolar radiofrequency energy or mechanical shaver debridement, 2% of patients in the bipolar radiofrequency energy group and 23% of patients in the mechanical shaver debridement group were using non-steroidal anti-inflammatory drugs at 1-year follow-up (p=0.026).

4.3                  In the randomised controlled trial of 60 patients treated by bipolar radiofrequency energy or mechanical shaver debridement, mean Knee injury and Osteoarthritis Outcome (KOOS) scores for pain, symptoms, activities of daily living, sports and quality of life (higher scores indicate better outcomes) were 81.2, 80.8, 81.5, 81.7 and 80.2 respectively in the bipolar radiofrequency energy group and 57.9, 58.3, 58.8, 57.3 and 56.2 respectively in the mechanical shaver debridement group at 1-year follow-up (p<0.001 for all inter-group comparisons). At 4-year follow-up, scores continued to be significantly higher for patients in the radiofrequency group: mean KOOS scores for pain, symptoms, activities of daily living, sports and quality of life were 75.1, 72.7, 69.9, 75.0 and 67.0 respectively in the radiofrequency group (n=25) and 55.7, 53.1, 50.9, 56.7 and 52.9 respectively in the mechanical shaver debridement group (n=15) (p<0.001 for all inter-group comparisons).

4.4                  A prospective case series of 15 patients (25 knees) treated by bipolar radiofrequency energy reported that the mean size of chondral defects decreased from 170.2 mm² (range 9–625 mm²) at initial arthroscopy to 107.7 mm² (range 0–300 mm²) at follow-up arthroscopy after a mean of 10.4 months: 32% (8/25) of defects showed no progressive damage to the articular surface; 32% (8/25) showed partial healing; and 24% (6/25) had healed completely. Twelve per cent (3/25) of defects showed unstable borders with progressive damage to the surrounding cartilage.

4.5                  A randomised controlled trial of 60 patients treated by monopolar radiofrequency energy plus mechanical shaver debridement (n=30) or mechanical shaver debridement only (n=30) reported that mean International Knee Documentation Committee (IKDC) score improved from 36 to 69 (p<0.05) and from 35 to 68 (p<0.05) respectively at a mean follow-up of 19 months (higher scores indicate better outcomes). No statistically significant differences in postoperative scores were observed between groups (p>0.05).  

4.6                  The specialist advisers stated that key efficacy outcomes include MRI findings and functional scores such as the Tegner, IKDC and Lysholm scores.

 

 

 

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview [add URL].

5.1                  A second-degree burn after radiofrequency chondroplasty was reported in the US Food and Drug Administration’s (FDA) manufacturer and user facility device experience (MAUDE) database. This was attributed to improper use of the radiofrequency equipment: a suction line, which should have been attached to the probe during the procedure, was not attached.

5.2                  Osteonecrosis of the medial femoral condyle was observed in 4% (2/50) of patients at a follow-up assessment that occurred at least 6 months after treatment, in a prospective case series of 50 patients. No clinical consequences were reported as a result of this.

5.3                  The confirmed or presumed detachment of a mechanical component of the radiofrequency probe within a patient’s knee was reported on 7 occasions between 2002 and 2012 in the MAUDE database.

5.4                  The specialist advisers stated that theoretical adverse events include excessive debridement of articular cartilage, avascular necrosis of the underlying bone, chondrocyte death and damage to surrounding cartilage and other structures.

 

 

 

6                      Committee comments

6.1                  The Committee originally intended to evaluate the use of arthroscopic radiofrequency chondroplasty of the knee for a variety of indications. However, most of the published evidence was for discrete chondral defects (mainly post-traumatic) in younger patients. There was insufficient evidence about its use in older patients with osteoarthritis for the Committee to comment on its use for that indication.

 

 

7                      Further information

7.1                  For related NICE guidance see the NICE website.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
November, 2013

 

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_{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}