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

Not Applicable

Withdrawn

• Conditions: Randomized Study; Non-operative Treatment; Plantar Fascitis; Surgical Treatment

• Registration Number: NCT05066919
• Lead Sponsor: Hvidovre University Hospital

Brief 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 %.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-04
• Study Start: 2022-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age > 18 years.
• Isolated plantar fasciitis through more than 6 months
• Ultrasonic verification of diagnosis (plantar fascia >4 mm)
• Ability to follow the post-operative- and conservative plans
• Able to give informed consent.

Exclusion Criteria

• Previous surgical treatment of plantar fasciitis or surgery around the heel
• Rheumatic disease
• Diabetes
• Dementia
• Neuropathy
• Known alcohol abuse
• Pareses/paralysis of the affected extremity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-Reported-Foot-And-Ankle Score (SEFAS)	24 Months	The questionnaire contains 12 items with 5 response options. The questionnaire covers different constructs, which are not reported separately in subscales. The most important of these constructs are pain, function, and limitation of function. Each of the 12 multiple-choice questions scores from 0 to 4 where a sum of 0 points represents the most severe disability and 48 represents normal function.

Trial Locations

Locations (1)

Hvidovre Hospital, Department of Ortopedic Surgery; 🇩🇰 Hvidovre, Denmark