Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy (PFX)

September 10, 2018 updated by: Region Skane
The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pin fixation and the risk for pin loosening and pintract infection is intimately connected Moroni et al., Magyar et al. Toksvig-Larsen and W-Dahl) The pin performance ratio for insertion to extraction torque (PPI) varies significantly between screw types.

The extraction torque force is the most important value and it is estimated that a removal torque around 300 Nm probably will be the best bon-pin fixation in clinical practice.

In animal studies and even in clinical studies the hydroxyapatite (HA) coated screw retained the highest level of osseointegration. However, the fixation for HAscrews is, especially in diaphyseal bone, the risk for too tight fixation, with extreme difficulties to remove the screws in few cases as a result ( high pain and seldom it is impossible to remove the screw) Coating by biphosphonate is a new novel technique with preclinical appealing performance, which theoretically should make this coating very appealing in clinical practice. The theory behind this technique is that it create a good pinfixation reasonable easy to remove.

The current most used cortical screw designs performed poorest in terms of fixation (PPI)

Method

Using the hemicallotasis technique for correction in high tibial osteotomies today, HA coated (Osteotite) conical 130/50 screws is used in the proximal tibia - the metaphysic - and plain (standard) cortical conical screws 110/40 is used in the diaphysis.

To study the effect of an improved pin coating a study including 30 patients randomised to the standard procedure today or the novel technique using biphosphonate coated screws.

In the metaphysic, the randomisation will be between the HA coated (Osteotite) screws and the biphosphonated coated screws 130/50 (screw thread 50mm) In the diaphysis the randomisation will be between the plain standard 110/40 screws and the biphosphonate 110/40 coated screws

Totally 30 patients will be studied which means totally 120 pins. This has been based on power calculations resulting in 23 patients in each group and calculated on extraction torque force. This is a clinical study and 30 patients is estimated due to expected drop out.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Hassleholm, Sweden, 28125
        • Orthopeadic Clinic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients which are diagnosed with arthr and needs an operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External pins coated by biphosfonate.
Device: Biphosfonate
External pins coated by biphosfonate.
Active Comparator: External pins coated by hydroxylapatite.
Device: Hydroxylapatit
External pins coated by Hydroxylapatit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical mode.
Time Frame: 2011-07-01-2012-02-01
To evaluate the relative osseomechanical strength of a novel coated pin/screw
2011-07-01-2012-02-01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Addbio AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFX-2009378

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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