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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Steven R. Clendenen, Mayo Clinic.
Recruitment status was:  Enrolling by invitation
Sponsor:
Information provided by (Responsible Party):
Steven R. Clendenen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01716650
First received: October 24, 2012
Last updated: April 10, 2015
Last verified: April 2015
  Purpose
To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle

Condition
Degenerative Joint Disease of the Ankle

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Steven R. Clendenen, Mayo Clinic:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Saphenous nerve block
Data collection after saphenous nerve block placement

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 24, 2012
Last Updated: April 10, 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

ClinicalTrials.gov processed this record on June 27, 2017