Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy
NCT ID: NCT01745276
Last Updated: 2018-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2011-04-30
2013-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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External pins coated by biphosfonate.
External pins coated by biphosfonate.
Biphosfonate
External pins coated by biphosfonate.
External pins coated by hydroxylapatite.
External pins coated by hydroxylapatite.
Hydroxylapatit
External pins coated by Hydroxylapatit.
Interventions
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Biphosfonate
External pins coated by biphosfonate.
Hydroxylapatit
External pins coated by Hydroxylapatit.
Eligibility Criteria
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Inclusion Criteria
20 Years
80 Years
ALL
No
Sponsors
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Addbio AB
INDUSTRY
Region Skane
OTHER
Responsible Party
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Locations
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Orthopeadic Clinic Hospital
Hässleholm, , Sweden
Countries
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Other Identifiers
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PFX-2009378
Identifier Type: -
Identifier Source: org_study_id
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