Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy

Osteoarthritis Clinical Trial

— PFX  

Official title:

Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745276
• Other study ID #: PFX-2009378
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: September 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Biphosfonate
External pins coated by biphosfonate.
• Hydroxylapatit
External pins coated by Hydroxylapatit.

Locations

Country	Name	City	State
Sweden	Orthopeadic Clinic Hospital	Hassleholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Addbio AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical mode.	To evaluate the relative osseomechanical strength of a novel coated pin/screw	2011-07-01-2012-02-01