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Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

Primary Purpose

Distal Fibular Fracture, Bimalleolar Fracture, Trimalleolar Fracture

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

biodegradable fixation system (Inion OTPS FreedomPlateTM)

About this trial

This is an interventional treatment trial for Distal Fibular Fracture focused on measuring retrospective, comparison, biodegradable, implant, ankle fracture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Leeds General Infirmary

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00864877

First Posted

March 18, 2009

Last Updated

March 18, 2009

Sponsor

Inion Oy

1. Study Identification

Unique Protocol Identification Number

NCT00864877

Brief Title

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

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Inion Oy

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Distal Fibular Fracture, Bimalleolar Fracture, Trimalleolar Fracture

Keywords

retrospective, comparison, biodegradable, implant, ankle fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

biodegradable fixation system (Inion OTPS FreedomPlateTM)

Other Intervention Name(s)

Inion OTPS(tm) FreedomPlate

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Giannoudis, Professor

Organizational Affiliation

Leeds General Infirmary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Leeds General Infirmary

City

Leeds

ZIP/Postal Code

LS13EX

Country

United Kingdom

12. IPD Sharing Statement

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Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

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