Tibial FracturesProxtibNCT03540719
Surgical Management of Posterior Tibial Plateau Fractures
An observational study of Tibial Fractures, run by Harm Hoekstra, prof. dr. at 4 sites in 3 countries.
Trial summary
This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 May 2018to 30 Oct 2020
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient at emergency room and clinic of the department of traumatology.
Who may be able to join
- Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis
Who cannot join
- Absent contact information
- living abroad and cannot participate in the follow-up visits
- non-functional leg prior to treatment/injury
- pathological fractures
- bilateral fractures
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).
- Conditions
- Tibial Fractures
- Being tested
- Osteosynthesis
- Keywords
- classification, questionnaires, open reduction, internal fixation
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective evaluation: outcome
Total Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire to measure patient's opinion about his or her knee and the associatede problems.
Measured: 1 year
Subjective evaluation: pain
Visual analogue scale (VAS) to indicate the daily pain level.
Measured: 1 year
Clinical evaluation
Recording of demographic and fracture-related characteristics.
Measured: 1 year
Radiographic evaluation
Parameters derived from CT and RX.
Measured: 1 year
Secondary outcomes (1)
Complications
Recording of complications: infection, nonunion, wound related problems, implant related complaints, compartment syndrome, neurological disorder, muscle atrophy and deep vein thrombosis.
Measured: 1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start30 May 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harm Hoekstra, prof. dr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Harm Hoekstra, prof. dr., Universitaire Ziekenhuizen KU Leuven
- Investigators
- Harm Hoekstra, Prof. MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540719
- Sponsor's protocol ID
- S60860
- Acronym
- Proxtib
- Status last verified
- Dec 2020
- First submitted
- 2 May 2018
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Posterior Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT03540719
- Acronym / sponsor ID
- Proxtib / S60860
- Conditions
- Tibial Fractures
- Keywords
- classification, questionnaires, open reduction, internal fixation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Harm Hoekstra, prof. dr.University, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 30 May 2018 (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.
This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient at emergency room and clinic of the department of traumatology.
Key inclusion criteria (1 listed)
- Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis
Key exclusion criteria (5 listed)
- Absent contact information
- living abroad and cannot participate in the follow-up visits
- non-functional leg prior to treatment/injury
- pathological fractures
- bilateral fractures
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 |
|---|---|---|
| OsteosynthesisOsteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate | Procedure or surgery | – |
Primary outcome
Subjective evaluation: outcome
Time frame: 1 year
Total Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire to measure patient's opinion about his or her knee and the associatede problems.
Subjective evaluation: pain
Time frame: 1 year
Visual analogue scale (VAS) to indicate the daily pain level.
Clinical evaluation
Time frame: 1 year
Recording of demographic and fracture-related characteristics.
Radiographic evaluation
Time frame: 1 year
Parameters derived from CT and RX.
1 secondary outcome
Complications
Time frame: 1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year
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 19 Dec 2020.
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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.
Harm Hoekstra, Prof. MD principal investigator
UZ Leuven
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibial Fractures, run by Harm Hoekstra, prof. dr. at 4 sites in 3 countries.
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 5 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Netherlands, Switzerland. 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?
Subjective evaluation: outcome (time frame: 1 year). The study lists 4 primary outcomes in all. 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 19 Dec 2020.