Tibial Fractures Clinical Trial
Official title:
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.
High-energy pilon fractures are associated with an increased risk of post-traumatic arthritis and poor patient outcomes. The risk of arthritis is over 25% in many series and can be upwards of 50% in more highly comminuted fracture patterns. Intraarticular fractures result in an increase in the synovial concentrations of inflammatory cytokines and matrix metalloproteinases. Animal models have demonstrated the irreversible damage a persistent hemarthrosis may have on cartilage viability suggesting that prolonged exposure to blood in this highly pro-inflammatory milieu may further exacerbate the chondral damage from the initial injury. However, the impact of these local inflammatory processes on the risk of post-traumatic arthritis and patient outcomes remain unclear. The long-term goal of our research is to develop treatment modalities including surgical and pharmaceutical interventions to reduce the risk post-traumatic arthritis and dysfunction following intraarticular fractures. The objective of this study is to determine the effect of ankle joint lavage on the risk of post-traumatic arthritis and patient outcomes following high-energy pilon fractures. First, we will obtain synovial fluid samples from the ankle joint of patients undergoing temporary external fixation of a pilon fracture for cytokine analysis. Then, we will randomize patients to undergo standard treatment with or without ankle joint lavage at the time of external fixation. Patients will undergo repeat synovial fluid analysis at the time of definitive fixation to determine the effect of lavage on the concentration of pro-inflammatory cytokines. Last, patients will be followed for a period of six months after surgery to determine the impact on functional outcomes. The information generated in this study will substantially add to our understanding of the pathogenesis of post-traumatic arthritis in high-energy pilon fractures. ;
| 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 | |
| Completed |
NCT01132508 -
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
|
N/A | |
| Terminated |
NCT00667849 -
Trial to Evaluate UltraSound in the Treatment of Tibial 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
|