A Pilot Study to Evaluate the Contribution of the Sapheno... | NCT01716650

Studies
A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle

NCT01716650

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Apr 8, 2019Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Degenerative Joint Disease of the Ankle

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no available participants

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Oct 24, 2012

First Submission Date that Met QC Criteria

Oct 25, 2012

First Posted Date

Oct 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2019

Last Update Posted Date

Apr 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Label	Type	Description	Intervention Names
Saphenous nerve block		Data collection after saphenous nerve block placement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ankle pain	Patient's ankle pain will be assessed prior to and after the nerve block. The study will assess if pain score is lower after the saphenous nerve block	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients evaluated with osteoarthritis who are surgical candidates for ankle fusion or total ankle replacement.
Registered patients at Mayo Clinic in Florida with scheduled visit to see Dr.Whalen

Exclusion Criteria:

Patients with lower extremity diabetic neuropathy
History of prior trauma of ankle with residual nerve injury
Current medication of pregabalin or gabalin
Allergy to lidocaine.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with degenerative joint disease of the ankle evaluated in the orthopedic department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Jacksonville	Florida	32224	United States