Wrist Injuries
Conditions
Brief summary
This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.
Detailed description
This is a prospective randomized control trial comparing three methods of treatment for acute DRUJ instability with or without concomitant distal radius fracture. Upon determination of residual DRUJ instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous DRUJ fixation with Kirschner wires, and open anatomic foveal repair of Triangular fibrocartilage complex TFCC ligaments with suture. Those patients undergoing Kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. Outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. Physician-based assessment of functional outcome with be assessed using the Disability of the Arm, Shoulder and Hand (DASH) score and Mayo Wrist scores, as well as independent assessment of DRUJ instability, ROM, and grip strength. Patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.
Interventions
PROCEDURESerial casting/splinting
Serial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs.
PROCEDUREPercutaneous fixation
Injury is treated by the percutaneous placement of Kirschner wires to promote healing. This is an invasive procedure, involving the placement of Kirschner wires to stabilize the wrist.
PROCEDUREFoveal repair
Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients treated at Orlando Regional Medical Center, 2. 18 years or older, 3. Have an acute (less than 4 week old) injury with instability of the DRUJ.
Exclusion criteria
1. Younger than 18 years old, 2. Patients with an injury over 4 weeks old, 3. Previous history of ipsilateral upper extremity trauma, 4. Functional deficit, 5. Those who are unable to complete postoperative assessments. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation and assessment of DASH scores. | Up to 5 years. | To compare the outcomes of the three treatment arms for acute DRUJ instability by assessment with the Disabilities of the Arm, Shoulder, and Hand (DASH) Score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain scale | Up to 5 years. | Patient will be asked to describe level on pain on a 10cm scale, in 1 cm increments, from 0 to 10. 0 equals no pain, 10 equals the worst pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mayo wrist assessment scores | Up to 5 years | Patients will be asked to describe their pain intensity, range of motion, grip strength and functional status. |
| Patient satisfaction | Up to 5 years | Patients will be asked to describe on a scale from 1 to 10 how satisfied they are with their surgery. |
Outcome results
None listed