OsteoarthritisPFXNCT01745276
Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy
A study testing Biphosfonate and Hydroxylapatit in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Biphosfonate and Hydroxylapatit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients which are diagnosed with arthr and needs an operation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Biphosfonate, Hydroxylapatit
- Keywords
- Pin fixation, Osteotomy, hemicallotasis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiphosfonateDevice
External pins coated by biphosfonate.
HydroxylapatitDevice
External pins coated by Hydroxylapatit.
| Study group | Role | What they receive |
|---|---|---|
| External pins coated by biphosfonate. | Experimental | External pins coated by biphosfonate. Receives: Device: Biphosfonate |
| External pins coated by hydroxylapatite. | Active comparator | External pins coated by hydroxylapatite. Receives: Device: Hydroxylapatit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2011-07-01-2012-02-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Addbio AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745276
- Sponsor's protocol ID
- PFX-2009378
- Acronym
- PFX
- Status last verified
- Sep 2018
- First submitted
- 23 May 2012
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy
- ClinicalTrials.gov ID
- NCT01745276
- Acronym / sponsor ID
- PFX / PFX-2009378
- Conditions
- Osteoarthritis
- Keywords
- Pin fixation, Osteotomy, hemicallotasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Addbio AB
- Study start
- Apr 2011 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External pins coated by biphosfonate. | Experimental | Device: BiphosfonateExternal pins coated by biphosfonate. |
| External pins coated by hydroxylapatite. | Active comparator | Device: HydroxylapatitExternal pins coated by hydroxylapatite. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients which are diagnosed with arthr and needs an operation.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiphosfonateExternal pins coated by biphosfonate. | Device | External pins coated by biphosfonate. |
| HydroxylapatitExternal pins coated by Hydroxylapatit. | Device | External pins coated by hydroxylapatite. |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphosfonate and Hydroxylapatit in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical mode. (time frame: 2011-07-01-2012-02-01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.