Clinical Research Directory

Below-Elbow Versus Initial Above-Elbow Casting for Distal Radius Fractures

The goal of this clinical trial was to compare two casting strategies for adults with a broken wrist, also called a distal radius fracture. The study included people whose treating team had determined that treatment without surgery was appropriate. Their fracture was first put back into position without surgery. The main questions were: * Does starting treatment with a below-elbow cast or an above-elbow cast affect how well the fracture stays in position? * Does cast length affect early elbow or shoulder pain and stiffness? * Does it affect grip strength, arm and wrist muscle recovery, wrist function, or long-term disability? Researchers compared a below-elbow cast used from the start with an above-elbow cast used for the first 2 weeks and then changed to a below-elbow cast. Participants: * were randomly assigned to one of the two casting strategies * wore a cast for 4 weeks, followed by a splint and rehabilitation * had x-rays and clinical assessments during the first 12 weeks * were scheduled for bilateral grip-strength and machine-based muscle-strength testing at cast removal and at 12 weeks * were invited to complete a clinical and functional follow-up assessment at approximately 5 years

Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.

Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures

The purpose of this research study is to determine if using a vibration tool improves pain control after surgical treatment of distal radius fracture. Additionally, the investigators would like to determine if this tool has any impact on consumption of pain medications postoperatively.

Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function

The goal of this clinical trial is to find out whether a therapist-guided exercise program helps people aged 50 and older recover better, in terms of pain and function, after a wrist fracture, compared to the usual care advice they would normally receive. The main question it aims to answer is: • Will participants who receive a therapist-supervised exercise program have better improvement in pain and function, as measured by the Patient Rated Wrist Evaluation questionnaire, six months after their injury? Researchers will compare these participants with those who receive usual care, which includes advice on self-management, to see if the supervised exercise program leads to greater recovery. Participants will: * Either receive supervised exercise, with a therapy session of up to 60 minutes and two additional sessions of up to 30 minutes each in addition to usual-care, or they will receive solely usual-care, consisting of advice on self-management. * Complete questionnaires electronically at baseline, 3-months, and 6-months.

Kinesiophobia and Functional Outcomes in Distal Radius Fractures

Distal radius fractures are among the most common fractures in adults and are frequently treated with closed reduction and cast immobilization. Although fracture healing is generally successful, some patients may develop fear of movement (kinesiophobia) after cast removal because of pain, reinjury concerns, or reduced confidence in using the injured wrist. The purpose of this study is to evaluate the level of kinesiophobia in adults with conservatively treated distal radius fractures and to investigate how kinesiophobia changes over time following cast removal. The study will also examine the relationship between kinesiophobia and functional recovery. Participants will be assessed after cast removal and again at three months following injury. Kinesiophobia, pain intensity, hand and wrist function, range of motion, grip strength, and upper extremity disability will be evaluated using standardized assessment tools. The findings may help clinicians better understand the role of movement-related fear in recovery and support the development of rehabilitation strategies aimed at improving functional outcomes after distal radius fractures.

Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

The purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (GC) injections versus those not receiving GCs for the treatment of distal radius fractures. The investigators hypothesize that patients who receive GC will have improved ROM and functional outcome measures compared to patients who do not receive GC. In addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the GC and non-GC groups. In order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.

Satisfaction and Recovery After Distal Radius Fracture

Distal radius fracture is the most common fracture in Sweden, but little is known about the patient's experience of pain and hand function during the first three months after the injury. This observational study will provide detailed information on a daily basis regarding pain, use of analgesic drugs, use of splints and hand function as measured weekly by a condition-specific questionnaire.

Evaluating the Effectiveness of Remote Monitoring for Post-Operative Management of Distal Radius Fractures

This randomized controlled trial evaluates whether remote monitoring can provide a safe and effective alternative to traditional in-person follow-up after surgical fixation of distal radius fractures. The study compares functional outcomes, patient satisfaction, and complication rates between patients who receive virtual follow-up care and those who attend standard in-person visits.

Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures

The purpose of this study is to see if splinting and formal physical therapy are necessary following surgical fixation (open reduction internal fixation) of distal radius fractures (broken wrist). Currently there is no consensus for post-operative protocol following fixation of distal radius fractures. The decision to splint (late mobilization) and prescribe formal physical therapy vs. not to splint (early mobilization) and use self-guided physical therapy is based on surgeon or institutional preference. The goal of this study is to determine if early mobilization leads to improved outcomes and decreased costs without increasing pain or the loss of hardware fixation.

The Investigation of Kinesiophobia in Conservative Distal Radius Fractures

This study aimed to investigate the predictability of kinesiophobia on functional outcomes in conservatively treated patients with distal radius fractures. For this purpose, patients' level of kinesiophobia will be assessed using the Tampa Kinesiophobia Scale. To assess the functional status of patients, joint range of motion and upper extremity weight bearing measurements will be performed. Patients' functionality will be additionally assessed with the Patient Rated Wrist Evaluation Questionnaire.

Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®

Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.

Hematoma Block for Distal Radius Fracture

The purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal radius fracture reduction.

Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures

This double-blind, randomized controlled clinical trial aims to evaluate the adjuvant effect of home-based photobiomodulation (PBM) therapy on the rehabilitation of surgically treated DRFs combined with an unsupervised home exercise program. A total of 42 participants will be randomly allocated into two groups. The Control Group will undergo the standard surgical procedure, perform the prescribed home exercises recommended by the hospital service, and use an inactive LED plate (photobiomodulation device). The PBM Group will follow the same surgical and exercise protocols but will use an active PBM device. Home exercises will begin 24 hours after surgery and should be performed twice daily for a total of 12 weeks. The device will be applied once daily to the wrist for 12 minutes (6 minutes on the dorsal side and 6 minutes on the palmar side). The primary outcome will be functional wrist assessment using the QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) questionnaire at 2 weeks. Secondary outcomes will include wrist range of motion, grip strength, wrist function, and pain (assessed using the PRWE-BR instrument), as well as fracture healing. Assessments will be performed at 2, 4, 6, and 12 weeks post-surgery, except for bone consolidation (assessed starting at week 4) and for pain and range of motion, which will also be evaluated at 24 hours.

Impact of Early ADL Participation on Outcomes Post DRF

This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated conservatively in a cast. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while in a cast and cast care. The control group will watch a video on cast care and be given a handout on cast care. Outcome measures will be taken at initial evaluation between 0-3 weeks, at 6 weeks, at 9 weeks, and at 3 months. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.

Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate

The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.

No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older

DISCLOSE trial is a randomized controlled trial including 532 participants with low-energy distal radius fractures. The primary objective is to evaluate whether casting without prior closed reduction is equivalent to casting following closed reduction with respect to wrist-related pain and disability, as measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months, in patients aged 65 years or older with a displaced distal radius fracture. * Primary endpoint will be PRWE at 12 months * Follow-up visits are scheduled at 3 and 12 months. 5-year follow-up will be considered as an exploratory endpoint

Minimal Clinically Important Difference of the Push-Off Test

The aim was to determine the minimal clinically important difference of the push-off test in distal radius fractures.

Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum Inflation Tourniquet Pressure.

Analyse surgical field bleeding, surgical time, and intraoperative pain in patients undergoing osteosynthesis of distal radius fractures using ischaemia pressure calculated based on Limb Occlusion Pressure, compared with Arterial Occlusion Pressure. Additionally, compare muscle damage and postoperative complications, and clinical, functional, quality of life and radiological outcomes at one-year follow-up.

Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk

The objective of this study is to determine whether a new minimally invasive method for in vivo measurement of cortical bone tissue properties can identify those who are at risk for fragility fractures of the hip and radius. The investigators hypothesis is that women with fragility fractures of the hip and radius have altered cortical bone tissue properties compared to non-fracture controls independent of standard clinical tests, such as bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).

Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair

The investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. Investigators will then evaluate tendon gliding morphology and number of tendon ruptures

Retrograde Elastic Nailing With Pollar K-wire in Metaphyseal Diaphyseal Fracture of Distal Radius in Pediatric Patients

Distal radius fractures are the most common fractures in the pediatric population . It accounts for 35% of all pediatric fractures . Although pediatric distal radius fractures can be successfully treated conservatively, reduction losses of 21-39% can be observed in the treatment with a plaster cast . Reduction losses are frequently observed in distal radius diaphyseal metaphyseal junctional (DRDMJ) fractures, primarily due to the limited contact surface of the fracture . There has yet to be a consensus regarding the treatment protocol for DRDMJ fractures . In DRDMJ fractures, surgery is recommended in cases where satisfactory alignment cannot be achieved with closed re-duction and cast immobilization, or there is reduction loss in clinical follow-ups .

Digital Aftercare for Wrist and Clavicle Fractures

This prospective, two-arm, open-label clinical trial compares digital aftercare with traditional follow-up in adult patients after surgical treatment of uncomplicated distal radius or clavicle fractures. The primary objective is to assess functional recovery at three months, using the Patient-Rated Wrist Evaluation (PRWE) for wrist fractures and the QuickDASH for clavicle fractures. Secondary outcomes include range of motion, patient satisfaction, quality of life, complication rates, healthcare costs, and work disability. In the digital aftercare group, program adherence and user experience will also be evaluated through app usage data and a structured questionnaire. The study aims to determine whether digital aftercare is a clinically and economically equivalent alternative to standard in-person care.

RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children

This is a pre-market, single-arm, open-label, monocenter clinical investigation evaluating the safety and performance of the magnesium (Mg)-based bioresorbable RemeOs™ DrillPin for surgical fixation of distal radius fractures in pediatric patients. The study will enroll 20 children aged over 5 and under 14 years to assess implantation success, early safety outcomes, and long-term effects on growth and bone healing.

Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius

The primary objective of this study is to demonstrate safety and efficacy of an early strengthening and passive mobilization rehabilitation program for post-operative distal radius fracture fixation surgery compared to current conventional rehabilitation.