Tibial Fractures Clinical Trial
— ProxtibOfficial title:
Surgical Management of Posterior Tibial Plateau Fractures
NCT number | NCT03540719 |
Other study ID # | S60860 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 30, 2018 |
Est. completion date | October 30, 2020 |
Verified date | December 2020 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 30 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis Exclusion Criteria: - Absent contact information - living abroad and cannot participate in the follow-up visits - non-functional leg prior to treatment/injury - pathological fractures - bilateral fractures |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Brussel | |
Belgium | UZ Leuven | Leuven | |
Netherlands | Erasmus MC Rotterdam | Rotterdam | |
Switzerland | Luzerner Kantonsspital Luzern | Luzern |
Lead Sponsor | Collaborator |
---|---|
Harm Hoekstra, prof. dr. |
Belgium, Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Primary | Subjective evaluation: pain | Visual analogue scale (VAS) to indicate the daily pain level. | 1 year | |
Primary | Clinical evaluation | Recording of demographic and fracture-related characteristics. | 1 year | |
Primary | Radiographic evaluation | Parameters derived from CT and RX. | 1 year | |
Secondary | Complications | Recording of complications: infection, nonunion, wound related problems, implant related complaints, compartment syndrome, neurological disorder, muscle atrophy and deep vein thrombosis. | 1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05459038 -
Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.
|
N/A | |
Terminated |
NCT02845245 -
Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques
|
N/A | |
Completed |
NCT02456194 -
Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
|
N/A | |
Terminated |
NCT00667849 -
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
|
N/A | |
Completed |
NCT01132508 -
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
|
N/A | |
Completed |
NCT00512434 -
Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
|
N/A | |
Completed |
NCT00161616 -
Study Evaluating InductOs in Diaphyseal Tibia Fractures
|
Phase 4 | |
Terminated |
NCT03881241 -
Safety Study of Treatment of Leg Fractures
|
||
Completed |
NCT02750072 -
INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
|
N/A | |
Completed |
NCT04015167 -
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
|
||
Recruiting |
NCT06451510 -
Knee Osteoarthritis in the Region of Norrbotten
|
||
Completed |
NCT05613257 -
Distal Targeter vs Free-hand
|
N/A | |
Completed |
NCT03388879 -
Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
|
N/A | |
Completed |
NCT02491047 -
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
|
N/A | |
Completed |
NCT01797640 -
Intramedullary Nailing of Tibia Fractures
|
N/A | |
Recruiting |
NCT03232216 -
Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
|
N/A | |
Withdrawn |
NCT03826784 -
Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures
|
Phase 3 | |
Terminated |
NCT00253981 -
Light Therapy in the Treatment of Leg Pain
|
N/A | |
Completed |
NCT05303389 -
Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures
|
N/A | |
Recruiting |
NCT05272631 -
Depuy Synthes Lower Extremity Shaft Nail Registry
|