Posters

A Randomized, Controlled, Double-Blind Study, Comparing the Results of Percutaneous Radiofrequency Micro-Fasciotomy with Percutaneous Plantar Fasciotomy

Shine John, DPM, Lowell Scott Weil, Sr. DPM, FACFAS, Lowell Weil, Jr. DPM, MBA, FACFAS, Anthony H. Borrelli, DPM, FACFAS, Gregory Amarantos, DPM, FACFAS, Wendy Benton-Weil, DPM, FACFAS, Robert Fridman, DPM, AACFAS, Jarrett Cain, DPM, Jason Glover, DPM, Weil Foot and Ankle Institute, Des Plaines, Il. www.weil4feet.com

Background

The use of plasma ablation, microtenotomy is becoming well established for treating chronic tendinopathy in the knee, elbow and shoulder(1-5). Recently, this technology has been applied to the treatment of chronic foot and ankle pathology as well, including plantar fasciosis, Achilles and posterior tibial tendinosis.

The purpose of this study was to evaluate the effectiveness of plasma RF-based microfasciotomy (P-RF-MF) for relieving pain associated with recalcitrant plantar fasciosis and, secondarily, to determine whether additional benefits, such as reduced incidence of postoperative complications and improved function, were observed compared to conventional surgical technique using percutaneous plantar fasciotomy (PPF).

Materials and Methods

Patients with chronic, refractory plantar fasciosis treated unsuccessfully using conservative care measures and whose next option was surgery, were approached to participate in the study. Computerized, random assignment into a surgical group of PPF or P-RF-MF took place during the surgery with both patients and the podiatric physicians conducting the follow-up examinations blinded to treatment.

The primary endpoint for patient evaluation is 3 months with a majority of follow-ups carried out to approximately 1 year. Inter-study protocol changes necessitated a dual report on secondary outcome measures. Clinical evaluation measures included ankle-hindfoot index score, visual analogue scale (VAS) pain score, SF-36 quality of life assessment, Roles and Maudsley score, and patient satisfaction.

The continuous variables were tested for normality and equal variance prior to parametric statistical analyses. If normality and equal variance are achieved, then parametric analyses (Student's t-test) were performed. If normality is not achieved, then a non-parametric test (Wilcoxon test) was applied. Categorical variables were analyzed using the Fisher's exact test or Chi-square test as appropriate. A minimum significance level of p=0.05 was used for all statistical tests.

Data/Tables

Table 1. Patient Demographics and Use of Conservative Care Measures

Tabel 2. Postoperative Change in AHI and Pain VAS Scores

Table 3. Pre- and Post-operative Roles and Maudsley Scores

Results

Pain associated with the surgical incision was the most important and commonly observed significant clinical event. This necessitated a protocol change that reduced this clinical event in both surgical groups.

Demographics of surgical groups were statistically similar (Table 1). Patients from both groups had an average age of approximately 48, mean BMI of 30, and the 2 of 3 patients were female. The conservative care measures taken prior to considering surgical intervention were also similar for both treatment groups. Over 80% of patients from both groups had found it necessary to modify their physical activities, and had tried orthotics, received at least one steroid injection, and used NSAIDs regularly.

Both surgical groups demonstrated significant improvement in post-operative function scores, as measured using the Ankle-Hindfoot Index score and Roles and Maudsley score, and significantly reduced pain scores, as measured using the visual analogue scale (VAS) score, post-operatively (Table 2; Table 3). Pre- and post-operative function and pain scores did not differ significantly between treatment groups. At 6 months, approximately two-thirds of patients in both surgical groups had good or excellent Roles and Maudsley score.

Quality of life (SF-36) scores were statistically similar for both surgical groups pre- and post-operatively. At 6 months, both groups demonstrated significantly (p<0.05) improved quality of life for most SF-36 components and scores fell within the normative standard for all components.

The proportion of patients satisfied with each surgical procedure at 3 and 6 months post-operatively was also statistically similar. At 6 months, 80% of patients were satisfied with the surgical procedure they had received.

Discussion and Conclusions

Micro-fasciotomy performed using plasma ablation appears to provide equally successful clinical results as plantar fasciotomy while sparing severing of the plantar fascia. Following protocol changes to MIS (minimally invasive surgery) for both techniques, early observations appear to suggest that subjects undergoing P-RF-PF based micro-fasciotomy returned to ADL (activities of daily living) more quickly than those subjects undergoing PPF.

1. Pulsed radiofrequency applied to the suprascapular nerve in painful cuff tear arthropathy. Kane TP, Rogers P, Hazelgrove J, Wimsey S, Harper GD. J Shoulder Elbow Surg. 2008 May-Jun;17(3):436-40.
   
   
2. Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Meknas K, Odden-Miland A, Mercer JB, Castillejo M, Johansen O. Am J Sports Med. 2008 Oct;36(10):1960-5.
   
   
3. Radiofrequency-based plasma microtenotomy compared with arthroscopic subacromial decompression yields equivalent outcomes for rotator cuff tendinosis. Taverna E, Battistella F, Sansone V, Perfetti C, Tasto JP. Arthroscopy. 2007 Oct;23(10):1042-51.
   
   
4. Microtenotomy using a radiofrequency probe to treat lateral epicondylitis. Tasto JP, Cummings J, Medlock V, Hardesty R, Amiel D. Arthroscopy. 2005 Jul;21(7):851-60.
   
   
5. Meniscal debridement with an arthroscopic radiofrequency wand versus an arthroscopic shaver: comparative effects on menisci and underlying articular cartilage. Allen RT, Tasto JP, Cummings J, Robertson CM, Amiel D. Arthroscopy. 2006 Apr;22(4):385-93.
   
   

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