Ankle FractureAnkleFXNCT02863042
Is Deltoid Ligament Repair for Ankle Fracture Necessary?
A study testing Repair Deltoid Tendon and Ankle Fracture Without Deltoid Tendon Repair in people with Ankle Fracture, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- Repair Deltoid Tendon and Ankle Fracture Without Deltoid Tendon Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 20 Aug 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Supination-external rotation ankle fracture with deltoid ligament incompetency
- Minimum of 2 year clinical follow up
Who cannot join
- Non-supination-external rotation ankle fracture
- Medial malleolus fracture
- Incomplete clinical or radiographic followup.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.
The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.
Read the detailed description
The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.
- Conditions
- Ankle Fracture
- Being tested
- Repair Deltoid Tendon, Ankle Fracture Without Deltoid Tendon Repair
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair Deltoid TendonProcedure or surgery
Ankle Fracture Without Deltoid Tendon RepairOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Deltoid Tendon Repaired | Experimental | Repair Deltoid Tendon Receives: Procedure: Repair Deltoid Tendon |
| Ankle Fracture Without Deltoid Tendon Repair | Other | Not described Receives: Other: Ankle Fracture Without Deltoid Tendon Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)
The 46-item SMFA questionnaire comprises two parts: the dysfunction index with 34 items and the bother index with 12 items. Each item has a 5-point response format (1 point for good function or not bothered and 5 points for poor function or extremely bothered).
The scores of the dysfunction and the bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula: (actual raw score - lowest possible raw score)/(possible range of raw score) × 100. This transformation formula gives the final scores, which ranged from 0 to 100. The higher scores indicate poorer function.
Measured: baseline, 6 month post-operative visit
Secondary outcomes (1)
Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale
The AOFAS Hindfoot Scale is an outcome rating system for ankle replacements. It is composed of the parameters pain (max 40 points), function (max 50 points) and alignment (max 10 points). Scores can range from 0 (severe pain, severely impaired function, and poor alignment) to 100 (no pain, no limitations on function, good alignment.)
Measured: 2 year postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Why it stopped: PI pulled the study. No participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn G. Shi, M.D., Mayo Clinic
- Investigators
- Glenn G Shi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863042
- Sponsor's protocol ID
- 16-003179
- Acronym
- AnkleFX
- Status last verified
- Aug 2018
- First submitted
- 19 May 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT02863042
- Acronym / sponsor ID
- AnkleFX / 16-003179
- Conditions
- Ankle Fracture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI pulled the study. No participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 11 Aug 2016 (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.
The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.
Detailed description
The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deltoid Tendon Repaired | Experimental | Procedure: Repair Deltoid TendonRepair Deltoid Tendon |
| Ankle Fracture Without Deltoid Tendon Repair | Other | Other: Ankle Fracture Without Deltoid Tendon Repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Supination-external rotation ankle fracture with deltoid ligament incompetency
- Minimum of 2 year clinical follow up
Key exclusion criteria (3 listed)
- Non-supination-external rotation ankle fracture
- Medial malleolus fracture
- Incomplete clinical or radiographic followup.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair Deltoid Tendon | Procedure or surgery | Deltoid Tendon Repaired |
| Ankle Fracture Without Deltoid Tendon RepairStandard of care | Other | Ankle Fracture Without Deltoid Tendon Repair |
Primary outcome
Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)
Time frame: baseline, 6 month post-operative visit
The 46-item SMFA questionnaire comprises two parts: the dysfunction index with 34 items and the bother index with 12 items. Each item has a 5-point response format (1 point for good function or not bothered and 5 points for poor function or extremely bothered). The scores of the dysfunction and the bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula: (actual raw score - lowest possible raw score)/(possible range of raw score) × 100. This transformation formula gives the final scores, which ranged from 0 to 100. The higher scores indicate poorer function.
1 secondary outcome
Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale
Time frame: 2 year postoperative visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Glenn G Shi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair Deltoid Tendon and Ankle Fracture Without Deltoid Tendon Repair in people with Ankle Fracture, 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 3 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: withdrawn, as of the sponsor's last update on 22 Aug 2018. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA) (time frame: baseline, 6 month post-operative visit). 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 22 Aug 2018.