Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia FractureThe Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.
Depuy Synthes Lower Extremity Shaft Nail Registry
Femoral FracturesTibial FracturesThe purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws...
Proximal Humeral FractureProximal Tibia Fractures1 moreThe study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates and Screws System (implants and instrumentation) when used to stabilize diaphyseal, proximal humerus and proximal tibia fractures. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
Post-traumatic; ArthrosisTibial Fractures1 moreHigh-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.
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
FracturesThe primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.
rhBMP-2 Versus Autograft in Critical Size Tibial Defects
Tibial FracturesThe purpose of our study is to evaluate the use of recombinant human bone morphogenetic protein 2 (RhBMP-2) as compared to standard ICBG in the treatment of severe open tibia fractures with a critical size bone defect (at least one centimeter in length compromising at least 50% of the circumference of the bone).
A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and...
Non-union Diaphysary Tibial FracturesThe researchers propose a prospective, randomised partially-blinded study to investigate the clinical and radiological outcome, effect on quality of life and socio-economic impact of non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft, in comparison to treatment with allograft together with DBM (demineralised bone matrix).
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Tibial FracturesThe purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
Light Therapy in the Treatment of Leg Pain
Tibial FracturesLeg InjuriesThe purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.
Intra-articular Local Anesthetic Injection and Hematoma Aspiration
Tibial FracturesThe primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee.