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Ankle Fractures clinical trials

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NCT ID: NCT02498717 Completed - Ankle Fractures Clinical Trials

Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures

Start date: June 3, 2015
Phase: N/A
Study type: Interventional

This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures.

NCT ID: NCT02481076 Active, not recruiting - Ankle Fractures Clinical Trials

Compression in Anklefracture Treatment, The CAT-study

CAT
Start date: November 2013
Phase: N/A
Study type: Interventional

The aim of this project is to find out if compression treatment can lower the incidens of surgical wound complications, such as infection and wound rupture, in patients with ankle fractures. The compression regime consists of a two-layered compression stocking applied after surgery and a massage boot applied both before and after surgery. The largest part of the study is the clinical trial, with which we aim to prove the hypothesis: * That the compression regime reduces wound infections from 10-40% to 5% on patients with a broken ankle (Either one side of the ankle, two or three sides (including the posterior part of the ankle))

NCT ID: NCT02480621 Completed - Ankle Fracture Clinical Trials

Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)

Start date: December 2014
Phase: Phase 3
Study type: Interventional

This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.

NCT ID: NCT02469506 Terminated - Immobilization Clinical Trials

Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

ANKL-ES
Start date: February 2015
Phase: N/A
Study type: Interventional

Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged period of immobilization in otherwise healthy individuals. Long-term immobilization of the lower extremity has shown to cause significant reductions in skeletal muscle mass, already occurring during the early stages of disuse. Accordingly, feasible strategies for attenuating this loss of muscle during disuse need to be pursued. Local neuromuscular electrical stimulation (NMES) offers such a potential strategy but, as yet, remains untested during prolonged muscle disuse in a clinical setting. Objective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates muscle loss during 2 weeks of unilateral ankle immobilization. Study design: Randomized, parallel (two groups) study design. Study population: 30 adults (18-65 y) with any form of closed ankle fractures needing surgical treatment. Intervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention. Main study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content, intramuscular triglyceride content and mRNA and protein expression of anabolic signaling proteins.

NCT ID: NCT02449096 Recruiting - Ankle Fractures Clinical Trials

Comparison of the Results of Complex Ankle Fractures Treated With and Without Ankle Arthroscopy

Start date: July 2015
Phase: N/A
Study type: Interventional

Background: An anatomical reconstruction of ankle congruity is an important prerequisite in the operative treatment of acute ankle fractures. But, despite an anatomic reduction, patients suffer from residual problems like chronic pain, stiffness, persistent swelling and instability after these fractures. There is growing evidence, that this poor outcome is related to the concomitant traumatic intraarticular pathology. Therefore, supplementary ankle arthroscopy has been proposed in acute ankle fractures as it is a valuable tool to confirm the anatomic reposition and to further identify and manage associated intraarticular injuries. The arthroscopic treatment of these pathologies might result in a better outcome after complex ankle fractures. Nevertheless, until now, the vast majority of ankle fractures are managed by open procedures only. Still, indications for arthroscopically assisted open reduction and internal fixation (AORIF) are not clearly stated, and the effectiveness of AORIF compared with open reduction and internal fixation (ORIF) has not yet been determined for complex ankle fractures. In this context, only a prospective randomized study can sufficiently answer these open questions. Therefore, the investigators plan a randomized controlled trial intended to report the short-, midterm- and long-term follow-up of patients who underwent operative treatment of acute ankle fractures - with and without ankle arthroscopy. Methods/Study design: The investigators will perform a randomized controlled trial evaluating the effect of AORIF compared to ORIF with a sample size of 40 patients per group. The investigators include patients with an acute ankle fracture after written informed consent. Primary outcome of the investigators' study is the difference of the AOFAS score (American Orthopedic Foot and Ankle Society) between the intervention (AORIF) and comparison (ORIF) group after a follow-up of 2 years. Several secondary outcome parameters will be assessed as well. Statistical analysis will be performed using a two-sided Student`s t-test. Discussion: Until today, there are only two randomized controlled trials evaluating the effect of open reduction and internal fixation (ORIF) compared to arthroscopically assisted open reduction and internal fixation (AORIF). Both studies only included patients with isolated fractures of the distal fibula at the level of the syndesmosis. These are the most simple fractures that are regularly treated operatively. Both studies documented a high incidence of intraarticular disorders in the AORIF group, but only one could show significant better results in the AORIF group. Moreover, several other studies could consistently demonstrate that the intraarticular damage is even more pronounced the more complex the fracture is. Consequently, a more distinctive effect of arthroscopy in complex fractures involving two malleoli or more has to be assumed when compared to these simple fractures.

NCT ID: NCT02444468 Recruiting - Ankle Fractures Clinical Trials

Preoperative Treatment of Malleolar Fractures

Start date: March 2015
Phase: N/A
Study type: Interventional

This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling. The investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.

NCT ID: NCT02373254 Completed - Ankle Fracture Clinical Trials

NSAIDS Versus Opioids in Acute SER II Ankle Fractures

Start date: January 2015
Phase: Early Phase 1
Study type: Interventional

This study is being conducted to evaluate whether NSAIDS are more or less effective in bone healing than opioids in acute fracture pain. Participants will be randomized to one of three groups for first line treatment of pain related to the fracture.

NCT ID: NCT02334618 Completed - Ankle Fracture Clinical Trials

Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.

NCT ID: NCT02281968 Withdrawn - Clinical trials for Closed Fracture of Ankle

NSAIDs for Pain After Ankle Fracture Surgery

Start date: December 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate if it is possible to decrease opioid consumption in patients undergoing ankle fracture surgery by providing scheduled doses of nonsteroidal inflammatory drugs (NSAIDs). This is a prospective, randomized, double-blinded, placebo controlled study with two groups of patients: one getting NSAIDs to take at regularly scheduled times plus a traditional prescription for opioid medication and one receiving the traditional prescription for opioid medication and a placebo. Patients will be assigned to a group from a computer-generated program. Neither the patients nor their doctors or nurses will know what group they are in, only the pharmacist will have that information. Patients in both groups will have the opportunity to take opioid medications if the pain becomes unmanageable.

NCT ID: NCT02245893 Active, not recruiting - Clinical trials for Fracture Dislocation of Ankle Joint

A Prospective Randomized Pilot Study to Compare Open Versus Percutaneous Syndesmosis Repair of Unstable Ankle Fractures

ART
Start date: August 2013
Phase: N/A
Study type: Interventional

This study evaluates fracture healing, anatomic reduction and return to functioning in patients with unstable Weber C type fractures of the ankle. Best outcomes are obtained when a good alignment of the ankle joint is maintained and natural function of the syndesmosis (space between the tibia and fibula bones) is restored. The syndesmosis and ankle joint is stabilized by a series of ligaments which are often damaged in Weber C type fractures. Current syndesmosis repair techniques traverse the tibia and fibula, but do not anatomically reconstruct the ligaments. The investigators will compare reconstruction of the unstable syndesmosis by open reduction and internal fixation using a syndesmosis screw coupled with anterior ligament (AiTFL) anatomic repair technique (ART) to percutaneous repair using a syndemosis screw only (SCREW). Radiographic, pain and functional outcome scores will be compared between the groups using validated outcome measures.