FracturesFACTSNCT02576730
Functional Outcome Assessment After (Calcaneal) Trauma Surgey
An observational study of Fractures and Trauma, run by Maastricht University Medical Center.
Trial summary
To include patient after traumatic (calcaneal) fractures for this study. They can be included to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the movement laboratory of the MUMC. Markers will be detached with dubble sided tape on anatomical points. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- ORIF
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Mar 2015
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects and patients after foot and ankle trauma fracture surgery
Who may be able to join
- patients with foot and ankle fractures
Who cannot join
- concomitant surgery for fractures of contra lateral leg/ankle or pre-existent abnormalities of the lower extremities, neurotrauma, spinal or neurological injury, pathologic fractures and people dependent in activities of daily living
About this study
To include patient after traumatic (calcaneal) fractures for this study. They can be included to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the movement laboratory of the MUMC. Markers will be detached with dubble sided tape on anatomical points. After that gait will be recorded with infra-red camera's and an animation model will be formed. With this model further analysis can be made to range of motion between different segement of the foot. These results will be compared with patient with an arthrodesis, healthy subjects, futher questionnaires, physical examination and radiographic findings will be correlated.
Read the detailed description
All subjects are asked to come to the movement laboratory of Maastricht University Medical Centre on one individual day. Before gait analyses the following characteristics were measured; height, weight, BMI, knee and ankle width (measured between the two condyles of the knee and the measured between the two malleoli of the ankle) and leg length . All measurements are performed by researchers who was trained in the examination of the foot. At least one static trial was performed with all 42 markers, with the subjects in stance phase in an anatomic neutral position. After calibrating the markers and calculating the subject-specific joint axes in the static trial, 6 markers were removed, according to the OFM protocol. After that the subjects were asked to walk barefoot in normal speed after a number of practice trials. For this speed at least 8 proper recordings were made during walking. The healthy subjects were also asked to walk in slow speed and 8 proper recordings were made during this slow-speed walking. One whole step was considered complete from heel landing (initial contact) to toe-off. A force plate was used to determine the heel-strike and toe-off phase during walking. Corrections in the axes of the knee and ankle were made if necessary and tiles were saved for further data output.
- Being tested
- ORIF
- Medical subject headings
- Fractures, Bone, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIFProcedure or surgery
surgery for foot and ankle fractures
| Study group | Role | What they receive |
|---|---|---|
| Fratures | patient with foot and ankle fractures and surgery with ORIF Receives: Procedure: ORIF | |
| healthy subjects | patients without foot and ankle fracture s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait in Patients After foot and ankle fractures range of motion
To measure range of motion in the foot and ankle with the OFM (range of motion in degrees) and compare between patients with foot and ankle fractures after surgery and healthy subjects range of motion between forefoot and hindfoot, hindfoot and tibia in 3 planes representing flexion/extension, abduction/adduction, inversion/eversion
Measured: 6 months after surgery
Secondary outcomes (1)
To find correlations between gait, questionnaires, radiographic findings and physical examination
correlations between gait (OFM, see above) AOFAS score (0-100_ Foot and ankle disability index FADI 0-100 VAS pain score (0-10) Short Form 36 SF 36 physical examination range of motion in the subtalar joint (inversion/eversion) in degrees en in the ankle (flexion/extension) degrees radiographic findings (in calcaneal patients, bohlers angle, gissane's angle) in general congruency of the joint with step-off and gap
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576730
- Sponsor's protocol ID
- NL34131.068.10/ MEC 10-3-072
- Acronym
- FACTS
- Status last verified
- Dec 2010
- First submitted
- 5 Oct 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome Assessment After (Calcaneal) Trauma Surgey
- ClinicalTrials.gov ID
- NCT02576730
- Acronym / sponsor ID
- FACTS / NL34131.068.10/ MEC 10-3-072
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Oct 2015 (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 include patient after traumatic (calcaneal) fractures for this study. They can be included to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the movement laboratory of the MUMC. Markers will be detached with dubble sided tape on anatomical points. After that gait will be recorded with infra-red camera's and an animation model will be formed. With this model further analysis can be made to range of motion between different segement of the foot. These results will be compared with patient with an arthrodesis, healthy subjects, futher questionnaires, physical examination and radiographic findings will be correlated.
Detailed description
All subjects are asked to come to the movement laboratory of Maastricht University Medical Centre on one individual day. Before gait analyses the following characteristics were measured; height, weight, BMI, knee and ankle width (measured between the two condyles of the knee and the measured between the two malleoli of the ankle) and leg length . All measurements are performed by researchers who was trained in the examination of the foot. At least one static trial was performed with all 42 markers, with the subjects in stance phase in an anatomic neutral position. After calibrating the markers and calculating the subject-specific joint axes in the static trial, 6 markers were removed, according to the OFM protocol. After that the subjects were asked to walk barefoot in normal speed after a number of practice trials. For this speed at least 8 proper recordings were made during walking. The healthy subjects were also asked to walk in slow speed and 8 proper recordings were made during this slow-speed walking. One whole step was considered complete from heel landing (initial contact) to toe-off. A force plate was used to determine the heel-strike and toe-off phase during walking. Corrections in the axes of the knee and ankle were made if necessary and tiles were saved for further data output.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fratures | – | Procedure: ORIFpatient with foot and ankle fractures and surgery with ORIF |
| healthy subjects | – | –patients without foot and ankle fracture s |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects and patients after foot and ankle trauma fracture surgery
Key inclusion criteria (1 listed)
- patients with foot and ankle fractures
Key exclusion criteria (1 listed)
- concomitant surgery for fractures of contra lateral leg/ankle or pre-existent abnormalities of the lower extremities, neurotrauma, spinal or neurological injury, pathologic fractures and people dependent in activities of daily living
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 |
|---|---|---|
| ORIFsurgery for foot and ankle fractures | Procedure or surgery | Fratures |
Primary outcome
Gait in Patients After foot and ankle fractures range of motion
Time frame: 6 months after surgery
To measure range of motion in the foot and ankle with the OFM (range of motion in degrees) and compare between patients with foot and ankle fractures after surgery and healthy subjects range of motion between forefoot and hindfoot, hindfoot and tibia in 3 planes representing flexion/extension, abduction/adduction, inversion/eversion
1 secondary outcome
To find correlations between gait, questionnaires, radiographic findings and physical examination
Time frame: 6 months after surgery
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 15 Oct 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures and Trauma, run by Maastricht University Medical Center.
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 1 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Gait in Patients After foot and ankle fractures range of motion (time frame: 6 months after surgery). 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 15 Oct 2015.