Ankle FracturePhase 4NCT01431560
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
A Phase 4 study testing fixation of the ankle fracture (Solco ) and fixation of the ankle fracture (Freedom) in people with Ankle Fracture, run by National Police Hospital at 1 site in South Korea.
Trial summary
The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- fixation of the ankle fracture (Solco ) and fixation of the ankle fracture (Freedom)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Aug 2011
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- skeletally mature subjects (≥16 years old) with unilateral ankle fractures
Who cannot join
- subjects less than 16 years old,
- subjects not followed up at this hospital,
- multiple injuries,
- bilateral ankle fractures,
- open fractures,
- pathologic fractures,
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- concomitant tibial shaft fractures,
- previous history of immobilization due to significant injury or a fracture of either ankle,
- significant peripheral neuropathy,
- soft tissue infection in the region on either injured ankle,
- or inability to complete the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.
- Conditions
- Ankle Fracture
- Being tested
- fixation of the ankle fracture (Solco ), fixation of the ankle fracture (Freedom)
- Keywords
- ankle, metallic, biodegradable, Freedom
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation of the ankle fracture (Solco )Device
Also called metallic implant: Solco
fixation with metallic implant
fixation of the ankle fracture (Freedom)Device
Also called biodegradable implant: Freedom
fixation with biodegradable implant
| Study group | Role | What they receive |
|---|---|---|
| metallic implant | Active comparator | fixation of the ankle fracture with metallic implants Receives: Device: fixation of the ankle fracture (Solco ) |
| biodegradable implant | Active comparator | fixation of the ankle fracture with Freedom plate and screws Receives: Device: fixation of the ankle fracture (Freedom) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopaedic Foot and Ankle Society(AOFAS) score
change from baseline(3 months after surgery)
Measured: 3 months, 6 months, 1 year
Secondary outcomes (1)
Short Musculoskeletal Functional Assessment(SMFA) scale
change from baseline (3 months after surgery)
Measured: 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionAug 2011
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Police Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jung Ho Noh, National Police Hospital
- Investigators
- Jung Ho Noh, M.D., Ph.D., Principal investigator, National Police Hospital, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431560
- Sponsor's protocol ID
- National Police Hospital
- Status last verified
- Sep 2011
- First submitted
- 2 Sep 2011
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
- ClinicalTrials.gov ID
- NCT01431560
- Acronym / sponsor ID
- National Police Hospital
- Conditions
- Ankle Fracture
- Keywords
- ankle, metallic, biodegradable, Freedom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- National Police HospitalOther government
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Sep 2011 (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 purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metallic implant | Active comparator | Device: fixation of the ankle fracture (Solco )fixation of the ankle fracture with metallic implants |
| biodegradable implant | Active comparator | Device: fixation of the ankle fracture (Freedom)fixation of the ankle fracture with Freedom plate and screws |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- skeletally mature subjects (≥16 years old) with unilateral ankle fractures
Key exclusion criteria (11 listed)
- subjects less than 16 years old,
- subjects not followed up at this hospital,
- multiple injuries,
- bilateral ankle fractures,
- open fractures,
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 |
|---|---|---|
| fixation of the ankle fracture (Solco )Also: metallic implant: Solcofixation with metallic implant | Device | metallic implant |
| fixation of the ankle fracture (Freedom)Also: biodegradable implant: Freedomfixation with biodegradable implant | Device | biodegradable implant |
Primary outcome
American Orthopaedic Foot and Ankle Society(AOFAS) score
Time frame: 3 months, 6 months, 1 year
change from baseline(3 months after surgery)
1 secondary outcome
Short Musculoskeletal Functional Assessment(SMFA) scale
Time frame: 3 months, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
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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.
Jung Ho Noh, M.D., Ph.D. principal investigator
National Police Hospital, Korea, Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fixation of the ankle fracture (Solco ) and fixation of the ankle fracture (Freedom) in people with Ankle Fracture, run by National Police Hospital at 1 site in South Korea.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 9 Sep 2011. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
American Orthopaedic Foot and Ankle Society(AOFAS) score (time frame: 3 months, 6 months, 1 year). 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 9 Sep 2011.