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Ankle Fractures clinical trials

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NCT ID: NCT05573516 Recruiting - Ankle Fractures Clinical Trials

A Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar Fractures

Start date: August 18, 2022
Phase: N/A
Study type: Interventional

A clinical trial comparing the outcomes of fixation of medial malleolar fractures either by fully threaded uni-cortical 4mm positional screws vs 4mm lag screws.

NCT ID: NCT05555459 Recruiting - Hallux Valgus Clinical Trials

Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

Start date: September 28, 2022
Phase: N/A
Study type: Interventional

The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.

NCT ID: NCT05494645 Recruiting - Pain, Postoperative Clinical Trials

Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.

NCT ID: NCT05465382 Recruiting - Clinical trials for Intra-Articular Fractures

Intra Articular Ankle Fractures

Start date: July 22, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment during the acute phase following intra-articular fracture of the human ankle. We hypothesize that early intervention with percutaneous joint lavage in the first 0-48 hours after injury will attenuate the production of pro-inflammatory cytokines, MMP's and cartilage breakdown products compared to non-lavaged control subjects at the time of surgical fixation.

NCT ID: NCT05445960 Recruiting - Ankle Fractures Clinical Trials

Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery

Start date: August 17, 2021
Phase: N/A
Study type: Interventional

This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.

NCT ID: NCT05419154 Recruiting - Clinical trials for Rehabilitation of Surgically Treated Ankle Fractures

Full-Weightbearing Following Ankle Fractures Surgically Treated - The FAST-Mobility Trial

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate complication rates and clinical outcome following mobilization and pain-dependent full weight-bearing in a large cohort of patients with surgically treated ankle fractures. The study design is a pragmatic, multi-center, multi-surgeon, prospective outcome study. Included will be adult patients with any isolated ankle fracture which was treated surgically without additional syndesmotic stabilization (suture-button or syndesmotic screw). Patients included are advised to conduct pain-dependent full weight-bearing without immobilization starting at the day of study inclusion. Follow-up points are 6 weeks, 3-, 6-, and 12 months. Data assessment include radiographic follow-up, complication assessment, return to work/sports, rang of ankle motion, and patient-rated outcome scores (MoxFQ, EFAS, OMAS, EQ-5D-5L). The primary outcomes are complications at 3 months and patient-rated outcome at 12 months. The sample size calculation revealed a final total sample size of 360 patients.

NCT ID: NCT05413707 Recruiting - Ankle Fractures Clinical Trials

Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

PMFIX
Start date: March 13, 2023
Phase: N/A
Study type: Interventional

Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF. Through a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients. Mason and Molly type 2A and 2B fractures will be included in the study.

NCT ID: NCT05412693 Recruiting - Ankle Fractures Clinical Trials

Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B Ankle Fractures

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

Stability dictates treatment choice for trans-syndesmotic fibula fractures. Optimal treatment for partially unstable fractures remains a topic of debate. The purpose of this study is to evaluate possible outcome non-inferior of functional orthosis treatment versus cast immobilization for these fractures.

NCT ID: NCT05391464 Recruiting - Clinical trials for Distal Radius Fracture

Nerve Block for Pain Control After Fracture Surgery

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

Surgical treatment for patients with a fracture of the ankle or distal radius is commonly offered on an outpatient basis. Patients are routinely discharged from hospital within 4 hours of their procedure. The surgery is commonly performed under peripheral nerve block with sedation, or under general anesthesia with postoperative peripheral nerve block, (if required for analgesic purposes). It is unclear which of these two strategies offers patients superior pain relief in the first few days following surgery. This trial aims to compare the pain intensity and analgesic medication consumption between patients in these two groups.

NCT ID: NCT05389436 Recruiting - Ankle Fractures Clinical Trials

Outpatient Versus Inpatient Surgery for Ankle Fractures

OVISAF
Start date: May 23, 2022
Phase: N/A
Study type: Interventional

This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.