Wounds and Injuries

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Fractures, Bone

Edema

Contracture

Radius Fractures

Hand Injuries

Dupuytren Contracture

Wrist Fractures

Forearm Injuries

Arm Injuries

Wrist Injuries

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

Coagulants

All Drugs and Chemicals

Central Nervous System Depressants

Anti-Infective Agents

Tranexamic Acid

Anesthetics

Anti-Bacterial Agents

Antibiotics, Antitubercular

Hemostatics

Antifibrinolytic Agents

Patients in the TXA arm will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before their surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after the first dose on the day of their surgery

Patients in the (SOC) arm will receive 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) before their surgery and 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) 3-6 hours after the first dose on the day of their surgery

Patients will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before your surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after your first dose on the day of your surgery

Tranexamic acid

This will include regional anaesthesia, tourniquet inflation to 250mmHg and perioperative antibiotics. At the conclusion of the procedure hemostasis will be achieved followed by standard closure technique. There will be three separate surgical groups that will undergo the outlined study protocol: 1) Distal radius fractures will be treated with open reduction from a volar approach only technique 2) Mild dupuytren's: a. Low: i. MCP joints \<50 contracture ii. PIP joints \<40 contracture b. 1-2 fingers involved 3) Severe dupuytren's a. High: i. MCP joints \>50 degree contracture ii. PIP Joints \>40 degrees contracture b. \>2 fingers involved

Surgery

Hand edema following hand surgery is a common yet devastating side effect that can lead to early stiffness, prolonged rehabilitation and diminished function. These factors can reduce a patient's quality of life; mounting to an overall delay in recovery, return to work and daily activities. Conventional edema therapy includes cryotherapy, external compression, active and passive exercises and various types of massage. However, there is little evidence to suggest these modalities are effective. Tranexamic acid (TXA) is an antifibrinolytic that has been used in surgical disciplines for decades to aid in reducing intraoperative blood loss and consequent transfusions. Recently, the use of TXA for curbing post-operative edema and ecchymosis has shown promising results, however, its use in hand surgery has not been studied.

A Prospective, Randomized Controlled, Double-Blinded Pilot Study

The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery

The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery (THAW): A Prospective, Randomized Controlled, Double-Blinded Pilot Study

Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%

Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%

Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate

Number of patients recruited to the study per month. The outcome goal will be 5 patients per month

Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.

Patient Reported Wrist and Hand Evaluation (PRWHE). The PRWHE allows patients to rate their levels of hand and wrist pain and disability. It is rated on a 0-100 scale. A higher score in the scale denotes a worse outcome

Ruby Grewal

Co-director of the clinical research lab within the Roth | McFarlane Hand and Upper Limb Center (HULC)

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Carpal Tunnel Syndrome

Trigger Finger Disorder

Cysts

Ganglion Cysts

Synovial Cyst

Median Neuropathy

Mononeuropathies

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nerve Compression Syndromes

Charcot-Marie-Tooth Disease

Hereditary Sensory and Motor Neuropathy

Cumulative Trauma Disorders

Sprains and Strains

Mucinoses

Tendon Entrapment

Tendinopathy

Hereditary Motor and Sensory Neuropathy

Hereditary Neuropathy With Liability to Pressure Palsies

Roussy Levy Syndrome

All patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities

a mobile app that demonstrates hand therapy exercises

Mobile App

Robin N Kamal, MD

Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.

Patients who are undergoing the included procedures will be informed of the study \& consented. They will be given information on how to download the app \& input their surgery date. The app will guide the patient through various hand therapy exercises and ask them to record their QuickDASH, PSFS and VAS Pain weekly.

Alternatives to Hand Therapy for Hand Surgery Patients

The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand. it is scored 0-100, with higher scores indicating higher disability

the PSFS is a validated measure of disability, that is scored on a 0-10 scale with lower scored indicating higher disability.

VAS pain is a validated measure of pain, scored 0-10, with higher scores indicating higher pain

Stanford University

Assistant Professor

Osteoarthritis

Soft Tissue Injuries

A protocol of exercises based on the current scientific evidence will be provided through a tablet application. A follow-up of the use of the application will be carried out. A minimum of 4-week home exercise intervention will be performed, which will have to be carried out daily by the patient autonomously at home for at least 5 days per week, starting after baseline measurement.

The exercise program will be individualized according to each pathology.

In the control condition, participants will receive a home exercise program on paper. The exercise program will be the conventionally prescribed one by the Andalusian Public Health Service. Participants will be told to perform exercises during a minimum of 4 week at home for at least 5 days per week, starting after baseline measurement.

Experimental: Tablet application

Comparator: Conventional treatment

Trauma and soft injuries of the wrist, hand and fingers have a high incidence, and large social and healthcare costs are generated, mainly due to productivity loss. Therapeutic exercises must be part of the treatment and in the last 10 years the scientific literature highlights the need for the inclusion of the sensorimotor system in both surgical and rehabilitative approaches. Current methods as leaflets or videos lacks of adherence control, evolution control and knowledge of how the patient do the exercises which compromise the expected results. Touch-screens of Tablet devices have showed a large potential to cover these needs and for the retraining of sensorimotor system. ReHand is a Tablet digital tool (Android and iOS) to prescribe and monitor exercise programs based on sensorimotor approach and developed under the guidelines of various healthcare professionals (hand surgeons, physiotherapists, rehabilitators and occupational therapists) to implement home exercise programs and monitor patients. Subjects are selected by emergency, hand surgery, rehabilitation and physiotherapy services of six hospitals from Andalusian Public Health Service through consecutive sampling. Concretely, patients over 18 years of age with trauma and soft injuries of the wrist, hand and fingers, no more than 10 days after surgery or removal of immobilization. Experimental group will receive access to ReHand app to perform a monitored home exercises program. Control group will receive the conventional method employed: a home exercise program in paper with recommendations. Clinical variables will be assessed at baseline before group allocation, 4 weeks, 3 months and 6 months. At the end of the study, cost-utility variables will be analyzed.

Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.

Clinical and Economic Effectiveness of a Tele-rehabilitation Evidence-based Tablet Application for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.

The shortened form of the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand questionnaire) is an 11-item questionnaire that measures patient's ability to complete tasks, absorb forces, and severity of symptoms.

The PRWE comprises a 5-item pain subscale and a 10-item function subscale. The final score is between 0 - 100 points with higher scores indicating more disability.

This test consists of placing nine small cylinders in the nine holes in the base or container of the "Nine Hole Peg Test".

The Maximun power of the hand muscles used to firmly grasp an object by wrapping the fingers around it, pressing it against the palm, and using the thumb to apply counter-pressure, using a Hydraulic grip dynamometer.

Participants report their pain intensity using the 0 to 10 VAS, where 0 refers to "no pain" and 10 refers to "the worst imaginable pain".

A test to evaluate the ability to accurately reproduce a specific joint angle without the vision of the joint.

Brief questionnaire which evaluated health state is in 5 domains: mobility, capacity for self-care, conduct of usual activities, pain or discomfort and anxiety or depression

Wrist flexion and extension range of movement assessed using a standard goniometer.

Absence due to illness, use of health resources (number of consultations to specialist doctor, physiotherapy occupational therapy sessions, emergency department), time frame in rehabilitation services.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery	NCT04907812	Hand Injuries a... Distal Radius F... Dupuytren Contr...	Tranexamic acid Surgery	18 Years -	Lawson Health Research Institute
Alternatives to Hand Therapy for Hand Surgery Patients	NCT03779958	Carpal Tunnel S... Trigger Finger Ganglion Cysts Distal Radius F... Finger Fracture De Quervain Syn...	Mobile App	18 Years - 100 Years	Stanford University
Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.	NCT04669704	Soft Tissue Inj... Distal Radius F... Metacarpal Frac... Carpal Fracture Carpal Tunnel S... Thumb Osteoarth... Dupuytren's Dis...	Experimental: T... Comparator: Con...	18 Years -	University of Seville
Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.	NCT04669704	Soft Tissue Inj... Distal Radius F... Metacarpal Frac... Carpal Fracture Carpal Tunnel S... Thumb Osteoarth... Dupuytren's Dis...	Experimental: T... Comparator: Con...	18 Years -	University of Seville
Alternatives to Hand Therapy for Hand Surgery Patients	NCT03779958	Carpal Tunnel S... Trigger Finger Ganglion Cysts Distal Radius F... Finger Fracture De Quervain Syn...	Mobile App	18 Years - 100 Years	Stanford University

Spots Global Cancer Trial Database for distal radius fracture