Clinical trial NCT00864877: Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Fibular Fracture
Bimalleolar Fracture
Trimalleolar Fracture
Keywords: retrospective
comparison
biodegradable
implant
ankle fracture
Lead sponsor: Inion Oy
Sponsor class: INDUSTRY
First posted: 2009-03-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 ¼ 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

Primary outcomes:
measure: The functional performance will be primarily determined by the Olerud and Molander Ankle Score
timeFrame: at 2, 6 and 12 weeks, and 12 and 24 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
Study officials:
affiliation: Leeds General Infirmary
name: Peter Giannoudis, Professor
role: PRINCIPAL_INVESTIGATOR
References: