ArthroscopyAABTFTPFNCT03327337
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures
A study testing Arthroscopic Assisted Balloon Tibioplasty in people with Arthroscopy and Tibial Fractures, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroscopy, Tibial Fractures, Orthopedic
- What is being tested?
- Arthroscopic Assisted Balloon Tibioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fresh closed fracture X-ray and CT examination confirmed Schatzker II-IV type tibial plateau fracture patients.
- the patient signed the informed consent.
Who cannot join
- Pathologic fractures, patients with neurologic disorders, and skeletally immature patients.
About this study
The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.
Read the detailed description
The Balloon Tibioplasty arthroscopic assisted forming technique based on the existing data, the subject of the design, 1. patients met the inclusion criteria, were randomized to traditional fracture tibial fixation or balloon assisted arthroscopic reduction under angioplasty, through follow-up, statistical evaluation after operation were compared between the two techniques for clinical curative effect the difference of tibial plateau articular surface reduction and recovery of joint function. 2., through the clinical practice, operation and experience summary, found that the new technology in the operation of the existing deficiencies, in order to improve the technology. 3 guide clinical diagnosis and treatment through results feedback and analysis.The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.
- Conditions
- Arthroscopy, Tibial Fractures, Orthopedic, Fracture Fixation
- Being tested
- Arthroscopic Assisted Balloon Tibioplasty
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Assisted Balloon TibioplastyProcedure or surgery
Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients Receives: Procedure: Arthroscopic Assisted Balloon Tibioplasty |
| control group | Other | operate with open reduction and internal fixation on this group patients Receives: Procedure: Arthroscopic Assisted Balloon Tibioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rasmussen scores change after surgery
the knee joint Rasmussen scores change after surgery
Measured: 3、6、12 and 24 mouth Rasmussen scores change after surgery
Rasmunssen radiological evaluation scores change after surgery
Rasmunssen radiological evaluation scores change after surgery
Measured: immediately, and at 2 weeks and 1, 3, 6, 12, and 24 months Rasmunssen radiological evaluation scores change after surgery
The quality of reduction
The quality of reduction will be determined based on postoperative CT scans, which can directly measure the amount of residual depression
Measured: 2 weeks and 1, 3, 6, 12, and 24 months postoperatively.
Secondary outcomes (6)
Intraoperative blood loss
blood loss in surgery
Measured: Operation day
Surgical duration
Surgical duration
Measured: The day of the operation
VAS pain scores change after surgery
The severity of lower limb pain after surgery
Measured: from the day of the operation to the day of discharge from hospital (up to 2 weeks).
Hospitalization period after surgery
Hospitalization period after surgery
Measured: The day of the operation to the day of discharge
Complications
Complications including wound infection, reoperations, and posttraumatic arthritis (PTA) will be recorded.
Measured: 1, 3, 6, 12, and 24 months follow-up time. (PTA may not be seen in patients within the 24-month follow-up period, and we will perform follow-up for at least 10 years in all patients.)
the Short-Form Health Survey (SF-36) questionnaire
Health-related quality of life will be measured using the Short-Form Health Survey (SF-36) questionnaire during follow-up.
Measured: 1, 3, 6, 12, and 24 months follow-up time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroscopyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327337
- Sponsor's protocol ID
- SAHoWMU-CR2017-08-105
- Acronym
- AABTFTPF
- Status last verified
- Aug 2019
- First submitted
- 18 Sep 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang JQ, Jiang BJ, Guo WJ, Zhang WJ, Li AB, Zhao YM. Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II-IV tibial plateau fractures: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 8;8(8):e021667. doi: 10.1136/bmjopen-2018-021667.
PubMed 30093519
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT03327337
- Acronym / sponsor ID
- AABTFTPF / SAHoWMU-CR2017-08-105
- Conditions
- Arthroscopy, Tibial Fractures, Orthopedic, Fracture Fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 Oct 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.
The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.
Detailed description
The Balloon Tibioplasty arthroscopic assisted forming technique based on the existing data, the subject of the design, 1. patients met the inclusion criteria, were randomized to traditional fracture tibial fixation or balloon assisted arthroscopic reduction under angioplasty, through follow-up, statistical evaluation after operation were compared between the two techniques for clinical curative effect the difference of tibial plateau articular surface reduction and recovery of joint function. 2., through the clinical practice, operation and experience summary, found that the new technology in the operation of the existing deficiencies, in order to improve the technology. 3 guide clinical diagnosis and treatment through results feedback and analysis.The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Arthroscopic Assisted Balloon Tibioplastyoperate with Arthroscopic Assisted Balloon Tibioplasty on this group patients |
| control group | Other | Procedure: Arthroscopic Assisted Balloon Tibioplastyoperate with open reduction and internal fixation on this group patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fresh closed fracture X-ray and CT examination confirmed Schatzker II-IV type tibial plateau fracture patients.
- the patient signed the informed consent.
Key exclusion criteria (1 listed)
- Pathologic fractures, patients with neurologic disorders, and skeletally immature patients.
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 |
|---|---|---|
| Arthroscopic Assisted Balloon TibioplastyUnder arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation | Procedure or surgery | control group, experimental group |
Primary outcome
Rasmussen scores change after surgery
Time frame: 3、6、12 and 24 mouth Rasmussen scores change after surgery
the knee joint Rasmussen scores change after surgery
Rasmunssen radiological evaluation scores change after surgery
Time frame: immediately, and at 2 weeks and 1, 3, 6, 12, and 24 months Rasmunssen radiological evaluation scores change after surgery
Rasmunssen radiological evaluation scores change after surgery
The quality of reduction
Time frame: 2 weeks and 1, 3, 6, 12, and 24 months postoperatively.
The quality of reduction will be determined based on postoperative CT scans, which can directly measure the amount of residual depression
6 secondary outcomes
Intraoperative blood loss
Time frame: Operation day
Surgical duration
Time frame: The day of the operation
VAS pain scores change after surgery
Time frame: from the day of the operation to the day of discharge from hospital (up to 2 weeks).
Hospitalization period after surgery
Time frame: The day of the operation to the day of discharge
Complications
Time frame: 1, 3, 6, 12, and 24 months follow-up time. (PTA may not be seen in patients within the 24-month follow-up period, and we will perform follow-up for at least 10 years in all patients.)
the Short-Form Health Survey (SF-36) questionnaire
Time frame: 1, 3, 6, 12, and 24 months follow-up time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 30093519Wang JQ, Jiang BJ, Guo WJ, Zhang WJ, Li AB, Zhao YM. Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II-IV tibial plateau fractures: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 8;8(8):e021667. doi: 10.1136/bmjopen-2018-021667.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Assisted Balloon Tibioplasty in people with Arthroscopy and Tibial Fractures, run by Second Affiliated Hospital of Wenzhou Medical University.
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 2 inclusion and 1 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Rasmussen scores change after surgery (time frame: 3、6、12 and 24 mouth Rasmussen scores change after surgery). The study lists 3 primary outcomes in all. 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 NCT03327337, which also lists 1 linked publication.
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 7 Aug 2019.