Degenerative Joint Disease of the AnkleNCT01716650
A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle
An observational study of Degenerative Joint Disease of the Ankle, run by Mayo Clinic at 1 site in United States.
Trial summary
To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Degenerative Joint Disease of the Ankle
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with degenerative joint disease of the ankle evaluated in the orthopedic department
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle
- Conditions
- Degenerative Joint Disease of the Ankle
- Keywords
- ankle, saphenous nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Saphenous nerve block | Data collection after saphenous nerve block placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: no available participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint Disease of the AnkleStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven R. Clendenen, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716650
- Sponsor's protocol ID
- 09-007710
- Status last verified
- Dec 2017
- First submitted
- 24 Oct 2012
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01716650
- Acronym / sponsor ID
- 09-007710
- Conditions
- Degenerative Joint Disease of the Ankle
- Keywords
- ankle, saphenous nerve block
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: no available participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saphenous nerve block | – | –Data collection after saphenous nerve block placement |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with degenerative joint disease of the ankle evaluated in the orthopedic department
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: no available participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease of the Ankle, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no available participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle pain (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.