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Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study

Plantar Fascitis Clinical Trial

Official title:
Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study

Clinical Trial Summary

The purpose of the study is to examine whether patients with heel spurs for more than 6 months, who have been treated conservatively, have better effect of surgery than further conservative treatment. The study is performed as a randomized trial with the inclusion of 32 patients divided between open plantar fasciectomy and conservative treatment. The primary endpoint is Self-Reported-Foot-And-Ankle Score (SEFAS-score) after 24 months. Secondary endpoints includes: Pain (Visual analogue score) at first step, rest and activity after 3, 6, 12 and 24 months, SEFAS-score after 3, 6 og 12 months, changes in gait after 6 months (measured with gait-analysis). All endpoints are measured at inclusion. The power calculation is based on the assumption that surgical treatment gives an improvement in SEFAS-score of 10 points (SD 7.9) after 24 months when compared to conservative treatment together with an alpha-value of 5 % and a beta value of 90 %.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05066919
Study type Interventional
Source Hvidovre University Hospital
Contact
Status Withdrawn
Phase N/A
Start date January 1, 2022
Completion date October 31, 2025
View Details
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