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

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ClinicalTrials.gov Identifier: NCT01745276
Recruitment Status : Unknown
Verified May 2012 by Region Skane.
Recruitment status was:  Active, not recruiting
First Posted : December 10, 2012
Last Update Posted : December 10, 2012
Sponsor:
Collaborator:
Addbio AB
Information provided by (Responsible Party):
Region Skane

Brief Summary:
The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Biphosfonate Phase 3

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy
Study Start Date : April 2011
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pin fixation Device: Biphosfonate
External pins coated by biphosfonate.



Primary Outcome Measures :
  1. To evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinivcal mode. [ Time Frame: 2011-07-01-2012-02-01 ]
    To evaluate the relative osseomechanical strength of a novel coated pin/screw



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients which are diagnostiserade med arthr and needs an operation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745276


Locations
Sweden
Orthopeadic Clinic Hospital
Hassleholm, Sweden, 28125
Sponsors and Collaborators
Region Skane
Addbio AB

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01745276     History of Changes
Other Study ID Numbers: PFX-2009378
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: May 2012

Keywords provided by Region Skane:
Pin fixation
Osteotomy
hemicallotasis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs