Depressed Tibial Plateau Fractures Clinical Trial
Official title:
Structural Bicortical Autologous Iliac Crest Bone Graft Combined With Tunnel Bone Tamps Method for Depressed Tibial Plateau Fractures
| NCT number | NCT04807062 |
| Other study ID # | ICBG001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2016 |
| Est. completion date | August 1, 2020 |
| Verified date | March 2021 |
| Source | Hebei Medical University Third Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Autologous ICBG and bone tamp methods are often applied to manage depressed tibial plateau fracture (DTPF), but previous iliac bone harvesting and bone tamp techniques remain controversial. The purpose of this study is to describe and evaluate the technique of using structural bicortical autologous iliac crest bone-graft (ICBG) combined with tunnel bone tamps method (TBTM) in treating DTPFs.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | August 1, 2020 |
| Est. primary completion date | February 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - adult patients (age = 18 years); - diagnosis of DTPFs; - agreeing to receive structural bicortical autologous ICBG combined with TBTM treatment and subsequent internal fixation treatment; - agreeing to participate in regular follow-up after surgery. Exclusion Criteria: - open fracture; - pathologic fractures; - bone metabolic disease; - previous ICBG; - infection or soft tissue injury of the iliac bone donor site; - pelvic fractures or bone tumors; - associated peripheral nerve injury; - non-completion of 30 months follow-up. |
| Country | Name | City | State |
|---|---|---|---|
| China | the Third Hospital of Hebei Medical University | Shijiazhuang | Hebei |
| Lead Sponsor | Collaborator |
|---|---|
| Hebei Medical University Third Hospital |
China,
Adams D, Patel JN, Tyagi V, Yoon RS, Liporace F. A simple method for bone graft insertion during Schatzker II and III plateau fixation. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):850-853. doi: 10.1007/s00167-018-5134-9. Epub 2018 Sep 12. — View Citation
Greimel F, Weber M, Renkawitz T, Voellner F, Freude T, Grifka J, Craiovan B. Minimally invasive treatment of tibial plateau depression fractures using balloon tibioplasty: Clinical outcome and absorption of bioabsorbable calcium phosphate cement. J Orthop — View Citation
Luo CF, Sun H, Zhang B, Zeng BF. Three-column fixation for complex tibial plateau fractures. J Orthop Trauma. 2010 Nov;24(11):683-92. doi: 10.1097/BOT.0b013e3181d436f3. — View Citation
Myeroff C, Archdeacon M. Autogenous bone graft: donor sites and techniques. J Bone Joint Surg Am. 2011 Dec 7;93(23):2227-36. doi: 10.2106/JBJS.J.01513. Review. — View Citation
Wang Z, Tian S, Zhao K, Zhang R, Yin Y, Zhu Y, Hou Z, Zhang Y. Neutrophil to lymphocyte ratio and fracture severity in young and middle-aged patients with tibial plateau fractures. Int Orthop. 2020 Dec;44(12):2769-2777. doi: 10.1007/s00264-020-04793-6. Ep — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative immediate reduction rate | Preoperative and postoperative imaging data of all subjects, including X-ray and CT scans, were collected. Picture Archiving and Communication Systems (PACS) was used to measure articular step-off and evaluate the immediate reduction after surgery. | up to 2 weeks | |
| Primary | Postoperative long-term reduction rate | The immediate postoperative and follow-up imaging data of all subjects, including X-ray and CT scan, were collected. PACS system was used to measure the articular step-off and evaluate the long-term reduction after surgery. | up to 2 weeks | |
| Primary | Bone healing time | Postoperative follow-up imaging data of all patients were collected, including X-ray and CT scans.Evaluating the bone healing time based on callus growth. | up to 2 weeks | |
| Secondary | operative time | The operation time in the bone graft donor site and bone graft site of all subjects was recorded as the basis for evaluating the size of surgical trauma. | up to 1 weeks | |
| Secondary | intraoperative blood loss | The intraoperative blood loss in the bone graft donor site and bone graft site of all subjects was recorded as the basis for evaluating the size of surgical trauma. | up to 1 weeks | |
| Secondary | The incidence of complications in the bone-graft donor and bone-graft sites | Surging-related complications of all subjects were recorded as a basis for evaluating surgical outcomes. | up to 1 weeks | |
| Secondary | the Visual Analog Scale scores of ICBG donor and bone-graft sites | The Visual Analog Scale pain scores (ranged from 0 to 10, 0 representing no pain and 10 representing maximal imaginable pain) of all subjects during postoperative follow-up were recorded as the basis for evaluating the surgical effect. | up to 1 week | |
| Secondary | Hospital for Special Surgery score of knee | The knee Hospital for Special Surgery scores (ranged from 0 to 100, 0 representing poor knee function and 100 representing normal knee function) of all subjects during the postoperative follow-up was recorded as the basis for evaluating the surgical effect. | uo to 1 week | |
| Secondary | 36-Item Short-Form Health Survey score | 36-Item Short-Form Health Survey scores (ranged from 0 to 100, 0 representing poor health and 100 representing normal health) of all subjects during postoperative follow-up were recorded as the basis for evaluating the surgical effect. | up to 1 week |