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

Hvidovre University Hospital

Status: Withdrawn

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

Treatments: Other: Conservative treatment; Procedure: Open plantar fasciotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05066919

78652

Details and patient eligibility

About

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 %.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Operative treatment

Experimental group

Description:

Patients treated with open plantar fasciotomy

Treatment:

Procedure: Open plantar fasciotomy

Conservative treatment

Active Comparator group

Description:

Patients treated non-operatively with exercise

Treatment:

Other: Conservative treatment