NCT02116478

Brief Summary

The purpose of the study is to compare the clinical results for patients suffering from plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 8, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

7.4 years

First QC Date

April 8, 2014

Last Update Submit

March 12, 2021

Conditions

Plantar Fasciitis

Keywords

plantar fasciitisgastrocnemius recession

Outcome Measures

Primary Outcomes (1)

  • Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score

    The change in AOFAS from baseline to follow-up, as well as the difference between the groups treated non-operatively and operatively will be reported on a 0-100 scale.

    1 year and 6 years postoperative

Secondary Outcomes (1)

  • 0-10 points Visual analog pain score

    1 year and 6 years postoperative

Other Outcomes (1)

  • Short form-36 (SF-36)

    1 year and 6 years postoperative

Study Arms (1)

gastrocnemius recession

EXPERIMENTAL

gastrocnemius recession

Procedure: surgical proximal medial gastrocnemius recession

Interventions

surgical proximal medial gastrocnemius recessionPROCEDURE

proximal medial gastrocnemius recession

gastrocnemius recession

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of plantar fasciitis lasting more than 12 months.
  • Isolated gastrocnemius contracture

You may not qualify if:

  • No previous surgery to foot or ankle
  • No active arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Marius Molund, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 17, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)