NCT00189592

Brief Summary

The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recurring plantar fasciosis and, secondarily, to determine whether there may be additional potential benefits stemming from its use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

September 12, 2005

Last Update Submit

August 25, 2015

Conditions

Plantar Fasciitis

Keywords

plantar fasciaplantar fasciitisCoblationfasciotomyconventional surgical fasciotomyheel spurheel painaponeurosisplasma based radiofrequencyangiogenesis

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    at 24 hours, 48 hours, 7 to 14 days, 4 to 6 weeks, 3 months, 6 months, 12 months

Secondary Outcomes (3)

  • Compare the number of postoperative complications

    When and if they occur

  • Evaluate changes in biomechanical function using Ankle-Hindfoot and Midfoot Scale

    4 to 6 weeks, 3 months, 6 months and 1 year

  • Assess function and quality of life by the sf-36 questionnaire

    at 4 to 6 weeks, 3 months, 6 months, 1 year

Study Arms (2)

A

EXPERIMENTAL

Percutaneous Fasciotomy

Device: ArthroCare TOPAZ™ MicroDebrider™ using Coblation

2

ACTIVE COMPARATOR

Standard Fasciotomy

Procedure: Surgical Fasciotomy

Interventions

ArthroCare TOPAZ™ MicroDebrider™ using CoblationDEVICE

Percutaneous treatment of plantar fascia using the Topaz device. No incision performed.

A
Surgical FasciotomyPROCEDURE

Standard surgical fasciotomy using an incision to treat the plantar fascia.

2

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of plantar fasciitis/fasciosis by all of the following:
  • Tenderness with palpation and local pressure over the medial calcaneal tuberosity on passive dorsiflexion of the foot
  • VAS (Visual Analog Scale) pain score of \> 5 points on a scale of 0 to 10, during the first few minutes of walking in the morning
  • Ultrasound or magnetic resonance imaging (MRI) confirming plantar fasciitis/fasciosis
  • Symptoms consistent with plantar fasciitis/fasciosis for at least 6 months as assessed by patient history
  • Pain unresponsive to non-steroidal anti-inflammatory drugs (NSAIDs) and any four of the following conservative treatments: rest, taping, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections for up to 3 months
  • Must be at least 18 years old and no more than 72 years old
  • Must sign the Institutional Review Board (IRB) approved informed consent form
  • Subject is willing and able to complete required follow-up

You may not qualify if:

  • Body mass index (BMI) \> 40
  • History or documentation showing type I and type II diabetes mellitus
  • Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
  • History or documentation showing peripheral vascular disease or autoimmune disease
  • Subject has received NSAIDs (e.g., ibuprofen, naproxen) for treatment of plantar fasciitis/fasciosis 2 weeks prior to treatment by this study
  • Subject has received NSAIDs (e.g. ibuprofen, naproxen) or oral corticosteroids 2 weeks prior to treatment by this study
  • Subject is receiving worker's compensation
  • Subject is currently involved in litigation related to the injury being studied
  • Prior surgical treatment of the plantar fascia(s) to be treated by this study
  • Subject is currently participating in another drug/device study related to the injured plantar fascia
  • Pregnant or pregnant suspected subjects
  • Clinically significant bilateral plantar fasciitis/fasciosis with a VAS pain scale of \> 5 bilaterally
  • Subject is not capable of understanding or responding to study questionnaires.
  • Extracorporeal shockwave therapy (ESWT) within 6 months of study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weil Foot & Ankle Institute

Des Plaines, Illinois, 60016, United States

Location

MeSH Terms

Conditions

Fasciitis, PlantarHeel Spur

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesExostosesHyperostosisBone Diseases

Study Officials

  • Lowell S. Weil, Sr., DPM

    Weil Foot & Ankle Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

US(1)