NCT00300989

Brief Summary

The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at below P25 for phase_2 surgery

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 5, 2007

Status Verified

October 1, 2007

First QC Date

March 9, 2006

Last Update Submit

October 4, 2007

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Functional performance will be determined by using Kaikkonen Functional Scale (Kaikkonen et. al. 1994) and Olerud and Molander Ankle Score (Olerud and Molander 1984) at 12 months post-operatively.

Secondary Outcomes (1)

  • Sequential post-operative radiographs at 12 months post-operatively; Timepoints for returning to work and/or sport; Wound healing; SF-36 Questionnaire; Subjective pain evaluation

Interventions

Inion OTPS Biodegradable Fixation SystemDEVICE

Eligibility Criteria

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

You may qualify if:

  • Distal fibular fracture including either instabile/dislocated Weber class B or any Weber class C fracture OR bimalloelar fracture with lateral malloelus fracture and medial malleolus fracture OR trimalleolar fracture with lateral and medial malleolus fractures and posterior malleolus fracture with less than 1/4 of the articulas surface fractured
  • Fresh/acute fracture
  • Aged between 18 and 60 years

You may not qualify if:

  • Contraindication for the Inion OTPS Biodegradable Fixation System:Active or potential infection,patient's conditions, limited blood supply, insufficient quantity or quality of bone,where patient cooperation can not be quaranteed
  • Multiple trauma
  • Previous ankle fracture
  • Pregnancy
  • Bone malignancy
  • Any clinically significant condition based on investigators judgement
  • high-load bearing applications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inion Oy

Tampere, 33520, Finland

Location

Study Officials

  • Ole Brink

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Terho Kainonen

    Turku Universal Central Hospital

    PRINCIPAL INVESTIGATOR

  • Geir Stray Andreassen

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 10, 2006

Study Start

December 1, 2005

Study Completion

May 1, 2007

Last Updated

October 5, 2007

Record last verified: 2007-10

Locations

FI(1)