Ankle Fractures

18

Review clinical trials related to Ankle Fractures. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Validation Study

Ankle fractures are common injuries that can affect a patient's mobility, mood, sleep, and everyday life for months. The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is an English-language patient-reported outcome measure developed in Australia to capture this broader rehabilitation experience. No validated Turkish version of A-FORM currently exists. This prospective multi-centre observational study aims to translate the A-FORM into Turkish (A-FORM-TR), culturally adapt it for use in Turkish-speaking patients, and evaluate its psychometric properties. The investigators will recruit 150 adults with a unilateral ankle fracture, treated either surgically or conservatively, from three orthopedic centres in Turkiye and the Turkish Republic of Northern Cyprus. Participants complete the A-FORM-TR together with two established comparator questionnaires (AOFAS Ankle-Hindfoot Score and the Turkish Olerud-Molander Ankle Score). A subset of approximately 50 participants is re-administered the A-FORM-TR after 7 to 14 days to assess test-retest reliability, with a Global Rating of Change item identifying clinically stable patients. Analyses include classical test theory, confirmatory factor analysis, and Rasch measurement analysis.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Utku GürhanUpdated: Jun 12, 2026Locations: 3
Eligibility criteria

Age 18 years or older [+5]

Bilateral ankle fracture [+7]

Status: Recruiting

Simplified Post Op Rehabilitation for Ankle and Pilon Fractures

The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.

Participants needed: 30
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: University of VirginiaUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Ages 18-65 [+1]

Contralateral lower extremity injuries that would limit weight bearing after 6 w... [+11]

Status: Recruiting

Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients

The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of pediatric and adolescent patients. The study aims to recruit 80 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 Lighthouse Hospital at Turku University Hospital (TYKS) in Finland. The main focus of the study in terms of performance is to follow up 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.

Participants needed: 80
Trial details
Age: Up to 17Biological sex: AllType: InterventionalSponsor: Inion OyUpdated: Jun 3, 2026Locations: 1
Eligibility criteria

Active infection [+6]

Status: Recruiting

Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures

The purpose of this prospective clinical trial is to compare the clinical outcomes and early wound complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Participants with fractures involving the posterior and lateral malleoli will undergo surgery using either a single-window technique (using a posterior antiglide plate) or a two-window technique (using a lateral anatomic plate). The main question the study aims to answer is whether the single-window approach reduces soft-tissue complications by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, implant irritation, and functional recovery.

Participants needed: 100
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: muhammed kılıçUpdated: Mar 20, 2026Locations: 1
Eligibility criteria

Patients aged between 18 and 65 years. [+3]

Open fractures, severe tibial pilon variants, or fractures with intra-articular... [+4]

Status: Recruiting

Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.

Participants needed: 56
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: Maimonides Medical CenterUpdated: Mar 20, 2026Locations: 1
Eligibility criteria

ankle fracture with syndesmotic disruption as assessed with intra-operative cott... [+6]

1) previous ankle surgery, 2) active local infection about the ankle, 3) chronic...

Status: Recruiting

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

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.

Participants needed: 125
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Inion OyUpdated: Mar 13, 2026Locations: 1
Eligibility criteria

Read the patient information bulletin on the study and signed the patient consen... [+5]

Active infection [+9]

Status: Recruiting

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale \[LEFS\]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.

Participants needed: 20
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: NYU Langone HealthUpdated: Feb 27, 2026Locations: 1
Eligibility criteria

Capable and willing to provide informed consent [+1]

Rheumatoid arthritis [+13]

Status: Recruiting

Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.

Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of California, San DiegoUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Ankle fracture with associated syndesmotic injury requiring surgery [+2]

Any not medically managed severe systemic disease [+5]

Status: Recruiting

FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)

This will be a multi-centre randomized controlled trial, with London Health Sciences Centre (LHSC) as the lead site. Elderly patients with complex ankle fractures who meet the inclusion criteria and provide consent will be randomized (through a web-based randomization system) to one of the two treatment arms. One group (Group A) will receive primary ankle fusion, and the second group (Group B) will receive primary ankle open reduction and internal fixation (ORIF). Patient important outcomes will be compared at one year post injury The Investigators have amended the study to include a second part for patients with less complicated but still unstable ankle fractures. In this part, patients will be randomly assigned to receive either a procedure called ORIF or another one called retrograde intramedullary fibular nailing.

Participants needed: 172
Trial details
Age: 40+Biological sex: AllType: ObservationalSponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUpdated: Jan 28, 2026Locations: 1
Eligibility criteria

Severe soft tissue compromise [+2]

Status: Recruiting

Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture

The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performance, and patient reported outcomes. The main questions it aims to answer are: 1. Assess feasibility and define the initial effects of the AMP program on ankle plantar flexor rate of torque development and ankle power. Primary hypothesis: an ankle muscle power program will have acceptable feasibility through assessment of 80% adherence, 90% treatment fidelity, recruitment (48 participants who complete the study), 80% retention, and 80% acceptability of the AMP program to facilitate clinical translation and the ability to scale-up the treatment. In addition ankle plantar flexor muscle power, plantar flexor RTD assessed isometrically, and ankle joint power, evaluated during gait and stair ascent/descent, will have significantly greater improvements in the AMP group than the standard of care group at the end of the intervention. 2. Test the effect of the AMP program on physical performance. Primary hypothesis: those completing the AMP program will have greater improvements in the 40 meter fast paced walk test and 11-stair climb test than those completing standard of care at the completion of the intervention. 3. Assess the preliminary efficacy of the AMP program on patient reported outcomes and quality of life. Primary hypothesis: compared to standard of care, the AMP program will result in improved quality of life on the ankle fracture outcome rehabilitation measure (A-FORM) Participants will complete rehabilitation and be assessed for outcomes at baseline and after completing the intervention. Additionally exploratory outcomes will be assessed 3 months after completing the intervention.

Participants needed: 60
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: Brian W. NoehrenUpdated: Dec 2, 2025Locations: 1
Eligibility criteria

Age 18-50 years old [+4]

History of chronic pain defined as pain lasting more than 3 months and bothersom... [+12]

Status: Recruiting

Randomized Controlled Trial for Ankle Fracture Pain Control

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.

Participants needed: 70
Trial details
Phase: Phase 4Age: 18-89Biological sex: AllType: InterventionalSponsor: Lahey ClinicUpdated: Nov 6, 2025Locations: 1
Eligibility criteria

Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fractu... [+1]

Unifocal malleolar fractures [+14]

Status: Recruiting

Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures

Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Kyle Schweser MDUpdated: Aug 24, 2025Locations: 1
Eligibility criteria

Adults 18 and ove [+6]

Children [+6]

Status: Recruiting

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.

Participants needed: 120
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Ostfold Hospital TrustUpdated: Aug 13, 2025Locations: 9
Eligibility criteria

isolated Weber type B fractures and Weber B+ posterior malleolar Mason Molloy cl... [+2]

assumed not compliant (drug use, cognitive- and/or psychiatric disorders). [+4]

Status: Recruiting

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

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.

Participants needed: 390
Trial details
Age: 18-89Biological sex: AllType: InterventionalSponsor: Oregon Health and Science UniversityUpdated: Mar 24, 2025Locations: 1
Eligibility criteria

Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixatio...

sepsis [+1]

Status: Not yet recruiting

Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial

Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group. Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.

Participants needed: 80
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: University of Puerto RicoUpdated: Jul 11, 2024
Eligibility criteria

Patients aged 21 years or older with isolated ankle fractures requiring surgical...

Patients that will be excluded from this study include those with complex ankle...

Status: Not yet recruiting

Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT

As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs. There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications. The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed. This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population.

Participants needed: 80
Trial details
Phase: Phase 1, Phase 2Age: 60+Biological sex: AllType: InterventionalSponsor: University of CalgaryUpdated: Mar 18, 2024
Eligibility criteria

Our study will include men and women over 60 years of age presenting to the emer...

Individuals will be excluded if they have received previous Teriparatide therapy...

Status: Recruiting

Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

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.

Participants needed: 198
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Haukeland University HospitalUpdated: Feb 29, 2024Locations: 1
Eligibility criteria

Posterior malleolar (PM) fracture, of Mason & Molly type 2A/2B, associated with... [+6]

Non-compliant patient, i.e.: dementia, alcohol- or substance abuse [+11]

Status: Not yet recruiting

Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.

Participants needed: 176
Trial details
Age: 16+Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Oct 17, 2023
Eligibility criteria

rotational ankle fracture Danis-Weber classification B or C fibula fracture [+3]