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
Distal radius fractures that are suitable for nonsurgical care are commonly treated with closed reduction and cast immobilization. Whether the elbow should be immobilized during the early treatment period remains uncertain. Above-elbow casting may restrict forearm rotation and theoretically improve fracture stability, but it may also cause elbow and shoulder discomfort or stiffness. Below-elbow casting preserves elbow movement and may reduce this treatment burden. This was a single-center, prospective, randomized, parallel-group clinical trial involving adults aged 18 to 70 years with eligible AO/OTA distal radius fractures. After the treating team established that nonsurgical treatment was indicated, participants underwent closed reduction and were assigned by web-based block randomization to one of two cast-immobilization strategies. Randomization therefore occurred after the indication for nonsurgical treatment had been established, not after nonsurgical treatment had been completed. Participants assigned to the below-elbow casting group received a below-elbow cast immediately after reduction. Participants assigned to the initial above-elbow casting group received an above-elbow cast immediately after reduction. At 2 weeks, the above-elbow cast was converted to a below-elbow cast. Cast immobilization ended at 4 weeks in both groups, followed by wrist splinting and rehabilitation. At the initial injury assessment on Day 1, grip-strength testing and Cybex isokinetic testing were performed only on the uninjured contralateral upper extremity. Bilateral grip-strength and Cybex assessments were performed at cast removal, 4 weeks after closed reduction, and again at 12 weeks. Cybex measurements included raw peak torque, peak torque normalized to body weight, raw work per repetition, work per repetition normalized to body weight, and range of motion during elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation. Side-to-side deficits were derived from the bilateral assessments at 4 and 12 weeks. Radiographic follow-up included measurement of radial inclination, radial height, ulnar variance, and volar tilt immediately after reduction, at 4 weeks, and at 12 weeks. Maintenance of reduction was evaluated as within-participant change in these radiographic parameters through 12 weeks. Early clinical outcomes included elbow or shoulder pain and stiffness at cast removal, grip-strength recovery, and patient-reported wrist and upper-extremity function. Complications, additional treatment, and conversion to surgery were monitored through the 12-week follow-up period. Patient-reported outcomes included the Patient-Rated Wrist and Hand Evaluation and the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. These measures were assessed during early follow-up and again at approximately 5 years. The long-term assessment also included treatment satisfaction. The 5-year assessment was limited to clinical and functional outcomes; Cybex isokinetic testing was not repeated at 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
A below-elbow cast was applied following closed reduction of the distal radius fracture. The cast was maintained until 4 weeks after reduction and was then removed. Splinting and rehabilitation followed cast removal.
An above-elbow cast was applied following closed reduction of the distal radius fracture. At 2 weeks, the above-elbow cast was converted to a below-elbow cast. All cast immobilization ended at 4 weeks after reduction, followed by splinting and rehabilitation.
Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
Istanbul, Turkey (Türkiye)
Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks
Peak torque measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities. Higher values indicate greater strength relative to body weight.
Time frame: 12 weeks after closed reduction
Raw Isokinetic Peak Torque at Cast Removal
Bilateral Cybex isokinetic dynamometry measured raw peak torque during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities in newton-meters. Higher values indicate greater maximal isokinetic strength.
Time frame: At cast removal, 4 weeks after closed reduction
Raw Isokinetic Peak Torque at 12 Weeks
Bilateral Cybex isokinetic dynamometry measured raw peak torque during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities in newton-meters. Higher values indicate greater maximal isokinetic strength.
Time frame: 12 weeks after closed reduction
Isokinetic Peak Torque Normalized to Body Weight at Cast Removal
Peak torque measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities. Higher values indicate greater strength relative to body weight.
Time frame: At cast removal, 4 weeks after closed reduction
Raw Isokinetic Work per Repetition at Cast Removal
Bilateral Cybex isokinetic dynamometry measured raw work per repetition during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities in newton-meters. Higher values indicate greater work performed per repetition.
Time frame: At cast removal, 4 weeks after closed reduction
Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal
Work per repetition measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities. Higher values indicate greater work capacity relative to body weight.
Time frame: At cast removal, 4 weeks after closed reduction
Isokinetic Range of Motion at Cast Removal
Bilateral range-of-motion values were recorded in degrees during Cybex testing for elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation. Values were recorded separately for the affected and unaffected upper extremities. Positive or negative values could be recorded according to the directional convention of the dynamometer.
Time frame: At cast removal, 4 weeks after closed reduction
Affected-to-Unaffected Isokinetic Deficit at Cast Removal
Affected-to-unaffected side deficits were calculated separately for raw peak torque, peak torque normalized to body weight, raw work per repetition, work per repetition normalized to body weight, and range of motion across the tested movements. Deficits were expressed as percentages relative to the unaffected side. Higher positive values indicate a greater deficit of the affected side; 0% indicates no side-to-side difference.
Time frame: At cast removal, 4 weeks after closed reduction
Bilateral Grip Strength at Cast Removal
Grip strength was measured in kilograms using a hand dynamometer. Three trials were recorded separately for the affected and unaffected hands. Higher values indicate greater grip strength.
Time frame: At cast removal, 4 weeks after closed reduction
Raw Isokinetic Work per Repetition at 12 Weeks
Bilateral Cybex isokinetic dynamometry measured raw work per repetition during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities in newton-meters. Higher values indicate greater work performed per repetition.
Time frame: 12 weeks after closed reduction
Isokinetic Work per Repetition Normalized to Body Weight at 12 Weeks
Work per repetition measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities. Higher values indicate greater work capacity relative to body weight.
Time frame: 12 weeks after closed reduction
Isokinetic Range of Motion at 12 Weeks
Bilateral range-of-motion values were recorded in degrees during Cybex testing for elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation. Values were recorded separately for the affected and unaffected upper extremities. Positive or negative values could be recorded according to the directional convention of the dynamometer.
Time frame: 12 weeks after closed reduction
Affected-to-Unaffected Isokinetic Deficit at 12 Weeks
Affected-to-unaffected side deficits were calculated separately for raw peak torque, peak torque normalized to body weight, raw work per repetition, work per repetition normalized to body weight, and range of motion across the tested movements. Deficits were expressed as percentages relative to the unaffected side. Higher positive values indicate a greater deficit of the affected side; 0% indicates no side-to-side difference.
Time frame: 12 weeks after closed reduction
Bilateral Grip Strength at 12 Weeks
Grip strength was measured in kilograms using a hand dynamometer. Three trials were recorded separately for the affected and unaffected hands. Higher values indicate greater grip strength.
Time frame: 12 weeks after closed reduction
Change in Affected-Hand Grip Strength From 4 to 12 Weeks
Grip strength of the affected hand was measured in kilograms using a hand dynamometer at 4 and 12 weeks. The analysis value at each assessment was derived from the recorded grip-strength trials. Change was calculated as the 12-week value minus the 4-week value. Positive values indicate improvement in affected-hand grip strength.
Time frame: 4 and 12 weeks after closed reduction
Change in Radial Inclination From Post-Reduction to 12 Weeks
Radial inclination was measured in degrees on anteroposterior wrist radiographs immediately after closed reduction and at 12 weeks. Change was calculated as the 12-week value minus the immediate post-reduction value. A negative change indicates loss of radial inclination.
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Change in Radial Height From Post-Reduction to 12 Weeks
Radial height was measured in millimeters on anteroposterior wrist radiographs immediately after closed reduction and at 12 weeks. Change was calculated as the 12-week value minus the immediate post-reduction value. A negative change indicates loss of radial height.
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Change in Ulnar Variance From Post-Reduction to 12 Weeks
Ulnar variance was measured in millimeters on anteroposterior wrist radiographs immediately after closed reduction and at 12 weeks. Change was calculated as the 12-week value minus the immediate post-reduction value. A positive change indicates increased positive ulnar variance.
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Change in Volar Tilt From Post-Reduction to 12 Weeks
Volar tilt was measured in degrees on lateral wrist radiographs immediately after closed reduction and at 12 weeks. Change was calculated as the 12-week value minus the immediate post-reduction value. A negative change indicates loss of volar tilt or progression toward dorsal tilt.
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Elbow or Shoulder Pain and Stiffness at Cast Removal
Participants rated elbow or shoulder pain and stiffness using a numeric scale from 0 to 10. A score of 0 indicates no elbow or shoulder pain or stiffness. Higher scores indicate greater symptom severity.
Time frame: At cast removal, 4 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 4 Weeks
The Patient-Rated Wrist and Hand Evaluation is a 15-item participant-reported questionnaire assessing wrist and hand pain and disability. The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
Time frame: At cast removal, 4 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 12 Weeks
The Patient-Rated Wrist and Hand Evaluation is a 15-item participant-reported questionnaire assessing wrist and hand pain and disability. The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
Time frame: 12 weeks after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 4 Weeks
The 11-item Quick Disabilities of the Arm, Shoulder and Hand questionnaire assesses upper-extremity symptoms and disability. The total score ranges from 0 to 100, with higher scores indicating greater disability.
Time frame: At cast removal, 4 weeks after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 12 Weeks
The 11-item Quick Disabilities of the Arm, Shoulder and Hand questionnaire assesses upper-extremity symptoms and disability. The total score ranges from 0 to 100, with higher scores indicating greater disability.
Time frame: 12 weeks after closed reduction
Number of Participants With Complications or Additional Treatment Through 12 Weeks
Number of participants with at least one cast-related or fracture-related complication, repeat reduction, conversion to surgery, unplanned change in immobilization, or other additional treatment during the first 12 weeks after closed reduction.
Time frame: From closed reduction through 12 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 5 Years
The Patient-Rated Wrist and Hand Evaluation is a 15-item participant-reported questionnaire assessing wrist and hand pain and disability. The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
Time frame: 5 years after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 5 Years
The 11-item Quick Disabilities of the Arm, Shoulder and Hand questionnaire assesses upper-extremity symptoms and disability. The total score ranges from 0 to 100, with higher scores indicating greater disability.
Time frame: 5 years after closed reduction
Treatment Satisfaction Score at 5 Years
Participants rated their satisfaction with the assigned casting treatment on a scale from 0 to 5. Higher scores indicate greater treatment satisfaction.
Time frame: 5 years after closed reduction
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