Open Fracture of FootNCT02910232
In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
An observational study of Open Fracture of Foot, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Fracture of Foot
- What is being tested?
- bone void filler
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2014to Jan 2016
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: There were 44 volunteers from orthopedic and neurosurgical division.
Who may be able to join
- A patient who requires treatment by surgery and product implant in bone.
- Not indicate sex type
- 18-65 years
- Patients accepted participate in the study.
- Type of surgery will be treat for only bone.
Who cannot join
- Refused to join the study.
- Patients have an allergic history of carbohydrates and bovine bone.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Biomedical Materials and Ceramic Industrial Research Unit
Chiang Mai, Chiang Mai, 50200
About this study
Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.
Read the detailed description
The products were prepared from medical grade Thai rice starch mixed with high purity (>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. There were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.
- Conditions
- Open Fracture of Foot
- Being tested
- bone void filler
- Keywords
- Rice starch, Porous composite, Biomaterial, Bone regeneration, Clinical trial, Hydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone void fillerDevice
Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration
| Study group | Role | What they receive |
|---|---|---|
| 1 | The groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts. Receives: Device: bone void filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone voids repairing
The primary outcome will be assessed from satisfactory grading by operative nurses and surgeons. Add a convenient storage, package removal, contamination risk, unused material disposal, size appropriateness, tolerability by hand, ease to cut, stability when wet, weight, and disturbance to operative field.
Measured: 6 months
Secondary outcomes (1)
Bone voids repairing
The short and long term safety and efficacy were assessed during real time operation, such as material dislodgement. Add a during follow up time for at least 1 months such as infection and allergic reaction by X-ray follow up assessment at 1, 3 and 6 months intervals, after operations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Open Fracture of FootStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sittiporn Punyanitya, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910232
- Sponsor's protocol ID
- 0425/58
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: yes, we plan
Publications
Holzapfel BM, Reichert JC, Schantz JT, Gbureck U, Rackwitz L, Noth U, Jakob F, Rudert M, Groll J, Hutmacher DW. How smart do biomaterials need to be? A translational science and clinical point of view. Adv Drug Deliv Rev. 2013 Apr;65(4):581-603. doi: 10.1016/j.addr.2012.07.009. Epub 2012 Jul 20.
PubMed 22820527Dimitriou R, Jones E, McGonagle D, Giannoudis PV. Bone regeneration: current concepts and future directions. BMC Med. 2011 May 31;9:66. doi: 10.1186/1741-7015-9-66.
PubMed 21627784Mendes SC, Reis RL, Bovell YP, Cunha AM, van Blitterswijk CA, de Bruijn JD. Biocompatibility testing of novel starch-based materials with potential application in orthopaedic surgery: a preliminary study. Biomaterials. 2001 Jul;22(14):2057-64. doi: 10.1016/s0142-9612(00)00395-1.
PubMed 11426886
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
- ClinicalTrials.gov ID
- NCT02910232
- Acronym / sponsor ID
- 0425/58
- Conditions
- Open Fracture of Foot
- Keywords
- Rice starch, Porous composite, Biomaterial, Bone regeneration, Clinical trial, Hydroxyapatite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Sep 2016 (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.
Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.
Detailed description
The products were prepared from medical grade Thai rice starch mixed with high purity (>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. There were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: bone void fillerThe groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- There were 44 volunteers from orthopedic and neurosurgical division.
Key inclusion criteria (5 listed)
- A patient who requires treatment by surgery and product implant in bone.
- Not indicate sex type
- 18-65 years
- Patients accepted participate in the study.
- Type of surgery will be treat for only bone.
Key exclusion criteria (2 listed)
- Refused to join the study.
- Patients have an allergic history of carbohydrates and bovine bone.
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 |
|---|---|---|
| bone void fillerBone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration | Device | 1 |
Primary outcome
Bone voids repairing
Time frame: 6 months
The primary outcome will be assessed from satisfactory grading by operative nurses and surgeons. Add a convenient storage, package removal, contamination risk, unused material disposal, size appropriateness, tolerability by hand, ease to cut, stability when wet, weight, and disturbance to operative field.
1 secondary outcome
Bone voids repairing
Time frame: 6 months
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 22 Sep 2016.
- Results publication: PubMed 22820527Holzapfel BM, Reichert JC, Schantz JT, Gbureck U, Rackwitz L, Noth U, Jakob F, Rudert M, Groll J, Hutmacher DW. How smart do biomaterials need to be? A translational science and clinical point of view. Adv Drug Deliv Rev. 2013 Apr;65(4):581-603. doi: 10.1016/j.addr.2012.07.009. Epub 2012 Jul 20.
- Results publication: PubMed 21627784Dimitriou R, Jones E, McGonagle D, Giannoudis PV. Bone regeneration: current concepts and future directions. BMC Med. 2011 May 31;9:66. doi: 10.1186/1741-7015-9-66.
- Results publication: PubMed 11426886Mendes SC, Reis RL, Bovell YP, Cunha AM, van Blitterswijk CA, de Bruijn JD. Biocompatibility testing of novel starch-based materials with potential application in orthopaedic surgery: a preliminary study. Biomaterials. 2001 Jul;22(14):2057-64. doi: 10.1016/s0142-9612(00)00395-1.
- Accessed 29 June 2016Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. yes, we plan
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?
An observational study of Open Fracture of Foot, run by Chiang Mai University at 1 site in Thailand.
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 5 inclusion and 2 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 22 Sep 2016. 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 Thailand. 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?
Bone voids repairing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910232, which also lists 3 linked publications.
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 22 Sep 2016.