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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
Sponsor:
Information provided by:
Inion Oy
ClinicalTrials.gov Identifier:
NCT00864877
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention
Distal Fibular Fracture
Bimalleolar Fracture
Trimalleolar Fracture
Device: biodegradable fixation system (Inion OTPS FreedomPlateTM)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Inion Oy:

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: May 2009
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: biodegradable fixation system (Inion OTPS FreedomPlateTM)
    Other Name: Inion OTPS(tm) FreedomPlate
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864877

Locations
United Kingdom
Leeds General Infirmary
Leeds, United Kingdom, LS13EX
Sponsors and Collaborators
Inion Oy
Investigators
Principal Investigator: Peter Giannoudis, Professor Leeds General Infirmary
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00864877     History of Changes
Other Study ID Numbers: D355 - 001
Study First Received: March 18, 2009
Last Updated: March 18, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Inion Oy:
retrospective
comparison
biodegradable
implant
ankle fracture

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

ClinicalTrials.gov processed this record on November 27, 2014