Unilateral Tibial Diaphyseal FractureT-PACNCT03100695
Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate
A study testing Concentrated autologous PRP-BMA in people with Unilateral Tibial Diaphyseal Fracture, run by University of Leeds at 1 site in United Kingdom.
Trial summary
A prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous PRP and concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed intramedullary nailing or fine wire ring… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unilateral Tibial Diaphyseal Fracture
- What is being tested?
- Concentrated autologous PRP-BMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2018to 31 Dec 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65, skeletally mature adults.
- Acute unilateral closed tibia diaphyseal fractures as the primary injury.
- Definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury.
- Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities.
Who cannot join
- Open/compound tibial fracture.
- Fracture Type 42-C2 according to Muller AO classification.
- Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.)
- Polytrauma (defined as injury severity score of 17 or more.)
- Prior or concomitant illnesses that may affect healing.
- Exposure to drugs that can affect the bone metabolic state within the past three months.
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- Receiving chemotherapy, radiation treatment or immunosuppression drugs.
- Currently enrolled in any other study which may impact on the results of the present study.
- If female: pregnancy, breast-feeding, not currently using and not willing to use an effective form of contraception for 12 months post-surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised, Single-centre Feasibility Study of Combined Autologous Platelet-rich Plasma and Concentrated Autologous Bone Marrow in Adult Patients With a Fresh Unilateral Tibial Diaphyseal Fracture Treated With Either Fine Wire Ring Fixator Device (Ilizarov) or Reamed Intramedullary Nailing
A prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous PRP and concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh tibial diaphyseal fractures.
- Conditions
- Unilateral Tibial Diaphyseal Fracture
- Being tested
- Concentrated autologous PRP-BMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated autologous PRP-BMAOther
Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will undergo operative procedure with no additional intervention. |
| Study | Experimental | Patients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation. Receives: Other: Concentrated autologous PRP-BMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing
Healing will be assessed both clinically and radiologically (RUST score)
Measured: 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start4 Oct 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Tibial Diaphyseal FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PeterGiannoudis, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100695
- Sponsor's protocol ID
- 226136
- Acronym
- T-PAC
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2017
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Single-centre Feasibility Study of Combined Autologous Platelet-rich Plasma and Concentrated Autologous Bone Marrow in Adult Patients With a Fresh Unilateral Tibial Diaphyseal Fracture Treated With Either Fine Wire Ring Fixator Device (Ilizarov) or Reamed Intramedullary Nailing
- ClinicalTrials.gov ID
- NCT03100695
- Acronym / sponsor ID
- T-PAC / 226136
- Conditions
- Unilateral Tibial Diaphyseal Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Apr 2017 (actual)
- 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.
A prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous PRP and concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh tibial diaphyseal fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will undergo operative procedure with no additional intervention. |
| Study | Experimental | Other: Concentrated autologous PRP-BMAPatients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65, skeletally mature adults.
- Acute unilateral closed tibia diaphyseal fractures as the primary injury.
- Definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury.
- Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities.
Key exclusion criteria (9 listed)
- Open/compound tibial fracture.
- Fracture Type 42-C2 according to Muller AO classification.
- Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.)
- Polytrauma (defined as injury severity score of 17 or more.)
- Prior or concomitant illnesses that may affect healing.
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 |
|---|---|---|
| Concentrated autologous PRP-BMAInjection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation. | Other | Study |
Primary outcome
Time to healing
Time frame: 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks
Healing will be assessed both clinically and radiologically (RUST score)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
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 Concentrated autologous PRP-BMA in people with Unilateral Tibial Diaphyseal Fracture, run by University of Leeds at 1 site in United Kingdom.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Time to healing (time frame: 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks). 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 25 Mar 2021.