NCT00864877

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

2.9 years

First QC Date

March 18, 2009

Last Update Submit

March 18, 2009

Conditions

Distal Fibular FractureBimalleolar FractureTrimalleolar Fracture

Keywords

retrospectivecomparisonbiodegradableimplantankle fracture

Outcome Measures

Primary Outcomes (1)

  • The functional performance will be primarily determined by the Olerud and Molander Ankle Score

    at 2, 6 and 12 weeks, and 12 and 24 months post-operatively

Interventions

biodegradable fixation system (Inion OTPS FreedomPlateTM)DEVICE
Also known as: Inion OTPS(tm) FreedomPlate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Osteomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds General Infirmary

Leeds, LS13EX, United Kingdom

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Peter Giannoudis, Professor

    Leeds General Infirmary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2012

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

GB(1)