An interventional study of Arthroscopic Assisted Balloon Tibioplasty in Arthroscopy, Tibial Fractures and Orthopedic, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Status unknown. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment
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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.
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.
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 91 interventional studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients
Procedure: Arthroscopic Assisted Balloon Tibioplasty
operate with open reduction and internal fixation on this group patients
Procedure: Arthroscopic Assisted Balloon Tibioplasty
Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation
Rasmussen scores change after surgery
the knee joint Rasmussen scores change after surgery
Time frame: 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
Time frame: 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
Time frame: 2 weeks and 1, 3, 6, 12, and 24 months postoperatively.
Intraoperative blood loss
blood loss in surgery
Time frame: Operation day
Surgical duration
Surgical duration
Time frame: The day of the operation
VAS pain scores change after surgery
The severity of lower limb pain 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
Hospitalization period after surgery
Time frame: The day of the operation to the day of discharge
Complications
Complications including wound infection, reoperations, and posttraumatic arthritis (PTA) will be recorded.
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
Health-related quality of life will be measured using the Short-Form Health Survey (SF-36) questionnaire during follow-up.
Time frame: 1, 3, 6, 12, and 24 months follow-up time
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Start is estimated for Jan 2020; primary completion for Dec 2022, 35 months later.
Of 39 interventional studies with no phase under Tibial Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 80. This study's planned 35 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University →