Trial record 3 of 409 for:
Open Studies | "Fractures, Bone"
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Inion Oy.
Recruitment status was Not yet recruiting
Information provided by:
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws and plates.
The objectives of the investigation are
- to compare post-operative fracture healing (union rates, time-to-union), and the complication rates (hardware failure, infection) between the two Plating Systems (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures
- to study the safety of the clinical application of the biodegradable plating system of Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.
Distal Fibular Fracture
Device: biodegradable fixation system (Inion OTPS FreedomPlateTM)
||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Primary Completion Date:
||April 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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 ¼ of the articular surface fractured
- Fresh/acute fractures (seen within seventy-two hours of the injury)
- Aged between 18 to 60 years
- Skeletally mature
- Willingness to accept randomisation either to the test or control group
- Willingness and ability to comply with all investigation procedures pre- and post-operation.
- Contraindications of operative internal plate fixations
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
- Multiple trauma, head injury, bilateral lower extremity fractures, upper extremity fractures
- Any concomitant painful or disabling disease of the lower limb that would interfere with evaluation of the affected ankle
- Previous ankle fracture
- Patients who most likely will not learn to walk with crutches (e.g., due to being severely overweight)
- Bone malignancy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864877
|Leeds General Infirmary
|Leeds, United Kingdom, LS13EX |
||Peter Giannoudis, Professor
||Leeds General Infirmary
No publications provided
History of Changes
|Other Study ID Numbers:
||D355 - 001
|Study First Received:
||March 18, 2009
||March 18, 2009
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Inion Oy:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Wounds and Injuries