|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00864877 |
|
Date of registration:
|
18/03/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
|
|
Scientific title:
|
A Randomised, Prospective Clinical Investigation to Compare Post-Operative Fracture Healing and Complication Rate After the Fixation of Ankle Fractures Using the Inion OTPS FreedomPlate Biodegradable Fixation System Versus Conventional Metal Screws and Plates. |
|
Date of first enrolment:
|
May 2009 |
|
Target sample size:
|
|
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00864877 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Peter Giannoudis, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Leeds General Infirmary |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Patient is willing and able to understand, sign and date the study-specific,
Institutional Review Board/Ethics Committee approved patient informed consent and
applicable privacy regulations.
2. Patient must require surgical treatment of a ankle fracture, with a distal fibular
(i.e., lateral malleolus) fracture (isolated, closed, unilateral, non-comminuted)
including either instable/dislocated Weber class B or any Weber class C fracture that
cannot be anatomically reconstructed accurately without open procedure, or
bimalleolar fracture with lateral malleolus fracture (as described above) and medial
malleolus fracture (closed, unilateral, non-comminuted), or trimalleolar fracture
with lateral and medial malleolus fractures as described above and posterior
malleolus fracture with less than ΒΌ of the articular surface fractured
3. Fresh/acute fractures (seen within seventy-two hours of the injury)
4. Aged between 18 to 60 years
5. Skeletally mature
6. Willingness to accept randomisation either to the test or control group
7. Willingness and ability to comply with all investigation procedures pre- and
post-operation.
Exclusion Criteria:
1. Contraindications of operative internal plate fixations
2. Contraindications for the Inion OTPS FreedomPlateTM Biodegradable Fixation System:
- active or potential infection
- patient's conditions, including limited blood supply, insufficient quantity or
quality of bone, and where patient cooperation cannot be guaranteed (e.g.,
alcoholism, drug abuse)
- high-load bearing applications
3. Multiple trauma, head injury, bilateral lower extremity fractures, upper extremity
fractures
4. Any concomitant painful or disabling disease of the lower limb that would interfere
with evaluation of the affected ankle
5. Previous ankle fracture
6. Patients who most likely will not learn to walk with crutches (e.g., due to being
severely overweight)
7. Bone malignancy
8. Osteomyelitis
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Bimalleolar Fracture
|
|
Distal Fibular Fracture
|
|
Trimalleolar Fracture
|
|
Intervention(s)
|
|
Device: biodegradable fixation system (Inion OTPS FreedomPlateTM)
|
|
Primary Outcome(s)
|
|
The functional performance will be primarily determined by the Olerud and Molander Ankle Score
[Time Frame: at 2, 6 and 12 weeks, and 12 and 24 months post-operatively]
|
|
Secondary ID(s)
|
|
D355 - 001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|