Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

Trimalleolar Fracture Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00864877
• Other study ID #: D355 - 001
• Status: Not yet recruiting
• Phase: N/A
• First received: March 18, 2009
• Last updated: March 18, 2009
• Start date: May 2009

Study information

• Verified date: March 2009
• Source: Inion Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Bimalleolar Fracture
• Distal Fibular Fracture
• Fractures, Bone
• Trimalleolar Fracture

Intervention

Device:
• biodegradable fixation system (Inion OTPS FreedomPlateTM)

Locations

Country	Name	City	State
United Kingdom	Leeds General Infirmary	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Inion Oy

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No