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

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ClinicalTrials.gov Identifier: NCT01716650
Recruitment Status : Unknown
Verified April 2015 by Steven R. Clendenen, Mayo Clinic.
Recruitment status was:  Enrolling by invitation
First Posted : October 30, 2012
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Degenerative Joint Disease of the Ankle

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle
Study Start Date : October 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Saphenous nerve block
Data collection after saphenous nerve block placement


Outcome Measures

Primary Outcome Measures :
  1. Ankle pain [ Time Frame: 30 minutes ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with degenerative joint disease of the ankle evaluated in the orthopedic department
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716650


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
More Information

Responsible Party: Steven R. Clendenen, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01716650     History of Changes
Other Study ID Numbers: 09-007710
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Steven R. Clendenen, Mayo Clinic:
ankle
saphenous nerve block

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases