Ankle FracturesNCT02823275
Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment
A study testing Functional mobilisation and Short term plaster cast fixation in people with Ankle Fractures, run by Rijnstate Hospital at 2 sites in Netherlands.
Trial summary
Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Functional mobilisation and Short term plaster cast fixation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2012to Nov 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 at the time of surgery
- Ankle fractures needing operative correction
- Weber type B or C, Lauge Hansen type supination-adduction, supination-external rotation and pronation-external rotation
- Closed fractures
- Postoperative stable for exercise
- Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem
Who cannot join
- Open fractures
- Fractures with complete dislocation of the ankle joint
- Body Mass Index > 30
- Previous ankle fracture on the affected side
- Concomitant traumatic injuries reducing the ability for postoperative mobilization
- Pre-existent use of pain medication, medication affecting fracture- and wound healing
- Postoperative unstable for exercise
- Co-morbidity: pain syndromes, Fontaine IIB, III and IV, symptomatic venous insufficiency, auto-immune disorders, rheumatic arthritis
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate
Arnhem, Gelderland
Radboud University
Nijmegen, Gelderland
About this study
Official title: Post Operative Evaluation of Quality of Life and Pain in Ankle Fractures: Cast Immobilisation Versus Functional Treatment
Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work.
Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities.
Read more
Main study parameters/endpoints:
Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications
- Conditions
- Ankle Fractures
- Being tested
- Functional mobilisation, Short term plaster cast fixation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional mobilisationOther
functional mobilisation
Short term plaster cast fixationOther
2 weeks cast immobilisation
| Study group | Role | What they receive |
|---|---|---|
| Functional mobilisation | Active comparator | Not described Receives: Other: Functional mobilisation |
| plaster cast fixation | Experimental | Not described Receives: Other: Short term plaster cast fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Visual Analog Pain Scale
Measured: 6 weeks
Pain medication used
amount of pain medication used
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Investigator changed jobs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823275
- Sponsor's protocol ID
- 683-250210-Nicolaas
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Evaluation of Quality of Life and Pain in Ankle Fractures: Cast Immobilisation Versus Functional Treatment
- ClinicalTrials.gov ID
- NCT02823275
- Acronym / sponsor ID
- 683-250210-Nicolaas
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator changed jobs
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Jul 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.
Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work.
Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities.
Main study parameters/endpoints:
Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional mobilisation | Active comparator | Other: Functional mobilisation |
| plaster cast fixation | Experimental | Other: Short term plaster cast fixation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 at the time of surgery
- Ankle fractures needing operative correction
- Weber type B or C, Lauge Hansen type supination-adduction, supination-external rotation and pronation-external rotation
- Closed fractures
- Postoperative stable for exercise
Key exclusion criteria (8 listed)
- Open fractures
- Fractures with complete dislocation of the ankle joint
- Body Mass Index > 30
- Previous ankle fracture on the affected side
- Concomitant traumatic injuries reducing the ability for postoperative mobilization
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 |
|---|---|---|
| Functional mobilisationfunctional mobilisation | Other | Functional mobilisation |
| Short term plaster cast fixation2 weeks cast immobilisation | Other | plaster cast fixation |
Primary outcome
pain
Time frame: 6 weeks
Visual Analog Pain Scale
Pain medication used
Time frame: 6 weeks
amount of pain medication used
Results and safety
The study was stopped early (reason given: Investigator changed jobs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional mobilisation and Short term plaster cast fixation in people with Ankle Fractures, run by Rijnstate Hospital at 2 sites in Netherlands.
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 6 inclusion and 8 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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: Investigator changed jobs). 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?
pain (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 6 Jul 2016.