Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00864877
Recruitment Status : Unknown
Verified March 2009 by Inion Oy.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2009
Last Update Posted : March 19, 2009
Information provided by:
Inion Oy

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.

Condition or disease Intervention/treatment Phase
Distal Fibular Fracture Bimalleolar Fracture Trimalleolar Fracture Device: biodegradable fixation system (Inion OTPS FreedomPlateTM) Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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 Start Date : May 2009
Estimated Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: biodegradable fixation system (Inion OTPS FreedomPlateTM)
    Other Name: Inion OTPS(tm) FreedomPlate

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00864877

United Kingdom
Leeds General Infirmary
Leeds, United Kingdom, LS13EX
Sponsors and Collaborators
Inion Oy
Principal Investigator: Peter Giannoudis, Professor Leeds General Infirmary Identifier: NCT00864877     History of Changes
Other Study ID Numbers: D355 - 001
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

Keywords provided by Inion Oy:
ankle fracture

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries