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Fractures, Bone clinical trials

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NCT ID: NCT03716661 Completed - Clinical trials for Distal Radius Fracture

Operative vs. Conservative Treatment of Distal Radius Fractures

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.

NCT ID: NCT03713853 Not yet recruiting - Acetabular Fracture Clinical Trials

Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement

GATOR
Start date: March 2024
Phase:
Study type: Observational [Patient Registry]

Management of acetabular (hip) fractures in the geriatric population can be very challenging because of pre-existing medical comorbidities, pre-existing osteoporosis and increased risk of mortality. The two most common treatment options for acetabular fractures are either surgical fixation using plates and screws to hold the fractured pieces in the correct position until the fracture has healed or surgical fixation in addition to a total hip replacement. Surgical fixation requires prolonged immobilization of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Such patients, especially those who are frail and cognitively impaired, are unable to adhere to the immobilization restrictions, leading to an increased risk of fixation failure. Patients who underwent open reduction internal fixation (ORIF) of an acetabular fracture were reported to have about 25 times greater incidence of hip replacement compared with general population matched controls. Additionally, performing a subsequent hip replacement after a previous surgical fixation (ORIF) of an acetabular fracture, especially in the elderly population, can present a number of technical difficulties including; difficult dissection due to previous incision(s) and scarring, dealing with retained hardware, bony deficiency and the possibility of infected hardware. The aim of the study is to perform a large cohort study to assess pain and physical function in patients 60 years and older who have sustained an acetabular fracture.

NCT ID: NCT03711812 Suspended - Anesthesia Clinical Trials

Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department

SABRE
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

The main aim of this study is to determine whether Serratus Anterior Plane (SAP) blockade provides improved pain relief after rib fractures compared to epidural administration of local anaesthetic. The investigators aim to show that SAP catheters (SAPC) can be placed in more situations and are less operator-dependent then thoracic epidural anaesthesia (TEA). This reduces the waiting time required to achieve satisfactory analgesia in the patient. Optimal analgesia allows early respiratory physiotherapy and reduction in the complications of multiple rib fractures. Pain from rib fractures is severe. The sensory nerves of the thoracic wall lie in the SAP and a single ultrasound-guided injection of local anaesthetic spreads widely and provides useful post-injury analgesia for several hours. If a catheter is left in the SAP, the nerve blockade can be maintained for several days. Rib Fracture pain is traditionally treated with oral/ intravenous analgesics or TEA. Opiate analgesia via patient controlled analgesia (PCA) can work very well but it is associated with excessive sedation, constipation, nausea and vomiting. Continuous TEA is generally regarded as the gold standard but it demands monitoring by adequately trained ward staff and is commonly associated with high failure rates and increased risk of complications. SAPC has also been used when TEA and PCA were not desirable. The primary outcome will be the amount of morphine analgesia required by the patient. Secondary outcomes will be pain scores (at rest and on movement), the side effects of morphine, complications of TEA/ SAPC, respiratory function changes and a quality of recovery assessment. The control group will have an epidural block and catheter placed. The treatment group will have SAP blocks and catheters placed under ultrasound guidance. Both blocks will be tested to ensure good pain relief. To avoid potential confounding effects, oral painkillers will adhere strictly to the study protocol.

NCT ID: NCT03705962 Terminated - Fractures, Open Clinical Trials

Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Start date: July 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.

NCT ID: NCT03696199 Recruiting - Ankle Fractures Clinical Trials

Randomized Controlled Trial for Ankle Fracture Pain Control

Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

NCT ID: NCT03695497 Completed - Clinical trials for Femoral Neck Fractures

Direct Anterior Approach for Femoral Neck Fractures

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.

NCT ID: NCT03695081 Completed - Aging Clinical Trials

Patient Pathway Pharmacist - Optimal Drug-related Care

Start date: September 3, 2018
Phase: N/A
Study type: Interventional

Medication errors represent the most common cause of patient injury and one of the most frequently reported health related deviation in Norway. The addition of a dedicated clinical pharmacist throughout the hip fracture patient pathway (patient pathway pharmacist) is believed to improve patient safety and ensure optimal drug-related patient care. The pharmacist will perform medication reconciliation at admission to hospital, medication review after surgery and assist physicians with discharge summary. Six weeks after discharge the patient pathway pharmacist will perform a second drug reconciliation and medication review. This study will assess the pharmacists' place and specific tasks in the patient pathway, describe areas where the pharmacist contribute to increased quality of care and assess the benefits and/or disadvantages experienced with introducing a patient pathway pharmacist. The estimated number of patients included is 60. Current practice will be determined by investigating the last 50 patients' medical record and a questionnaire to health care professionals involved in treatment of hip fracture patients. Data from medication reconciliation and drug review will be collected and compared to current practice. After the inclusion period, focus group surveys and/or semi-structured interviews will be executed to describe the perceived improvement in the quality of care. Primary endpoints are: 1) Medication reconciliation score at admission 2) Number of inappropriate drugs for elderly 3) Discharge summary score 4) Discharge summaries following procedure. Secondary endpoints are readmissions and mortality after 30 and 90 days. Qualitative endpoints: 1) Health care professionals experience of current drug-related practice 2) Experienced advantages and disadvantages of a patient pathway pharmacist.

NCT ID: NCT03694457 Recruiting - Humeral Fracture Clinical Trials

Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

DELTOSUPEX
Start date: November 26, 2018
Phase: N/A
Study type: Interventional

The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

NCT ID: NCT03692260 Not yet recruiting - Clinical trials for Minimally Displaced Mandibular Angle Fracture

Fracture Gap After Herbert Screw Insertion by 3d Stents Vs Titanium Plate(Minimally Displaced Mandibular Angle Fracture)

Start date: October 25, 2018
Phase: N/A
Study type: Interventional

interfragmentary gap measurement using Herbert cannulated headless screw using a 3D surgical customized template versus titanuim plate

NCT ID: NCT03689335 Completed - Clinical trials for Closed Fracture of Shaft of Humerus

HUmeral Shaft Fracture FIXation Study

HU-FIX
Start date: September 17, 2018
Phase: N/A
Study type: Interventional

Fractures of the humeral shaft (upper arm bone) account for approximately 1% of all adult fractures in the United Kingdom. Historically, these injuries have been treated using a cast and/or brace, with immediate surgical fixation reserved for severely- or multiply-injured patients. However, treatment with a brace is associated with several important problems, including poor alignment of the healed bones and shoulder/elbow stiffness. The brace is usually worn for up to 3 months, which interferes with patients' everyday activities and sleeping, and can predispose to skin problems. For 10-15% of patients treated with a brace, their fracture will not heal and will require surgery several months after the original injury, which is more difficult and carries a higher risk of complications. Recent studies suggest that undertaking immediate surgical fixation more often could improve healing and functional outcome for patients with humeral shaft fractures. The only published randomised controlled trial (RCT) to date showed no difference in clinical outcome between conservative and operative management; unfortunately, however, the operative technique used was unusual and would be considered highly suboptimal in most Western countries. This study will include adult patients (≥16 years), with capacity to consent and complete post-operative questionnaires in English, presenting to a single Orthopaedic trauma unit. Participants will be randomised to either non-operative treatment (with a brace) or operative treatment (i.e. surgical fixation). The investigators will assess whether there is a difference between the groups in terms of patient-reported outcome scores, fracture healing, complications, pain and return to work/sport over a one-year follow-up period. Participants will be enrolled into the study after obtaining informed consent. Following randomisation (to either non-operative treatment or surgical fixation), participants will then be reviewed at several defined timepoints, with a combination of clinical examination, X-rays and patient-reported outcome scores. The investigators hope that study results will enable surgeons to make better-informed decisions when managing patients with humeral shaft fractures.