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Completed

NCT Number: NCT07704879

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

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 70 years
  • Closed distal radius fracture for which the treating team determined that nonsurgical treatment with closed reduction and cast immobilization was appropriate
  • AO/OTA distal radius fracture classified as 2R3A2, 2R3A3, 2R3B2, 2R3B3, 2R3C1, 2R3C2, or 2R3C3

Exclusion criteria

  • AO/OTA distal radius fracture classified as 2R3A1 or 2R3B1
  • Open distal radius fracture
  • History of an allergic reaction to cast material
  • Previous surgery involving the wrist or elbow
  • Distal radius fracture judged to require operative treatment at the initial evaluation

Treatment and study plan

Below-Elbow Cast Immobilization

Procedure

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.

Other names: Short-Arm Cast Immobilization

Initial Above-Elbow Cast Followed by Below-Elbow Cast

Procedure

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.

Other names: Initial Long-Arm Cast Followed by Short-Arm Cast

Primary outcomes

  1. Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

Secondary outcomes

  1. Raw Isokinetic Peak Torque at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  2. Raw Isokinetic Peak Torque at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  3. Isokinetic Peak Torque Normalized to Body Weight at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  4. Raw Isokinetic Work per Repetition at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  5. Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  6. Isokinetic Range of Motion at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  7. Affected-to-Unaffected Isokinetic Deficit at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  8. Bilateral Grip Strength at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  9. Raw Isokinetic Work per Repetition at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  10. Isokinetic Work per Repetition Normalized to Body Weight at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  11. Isokinetic Range of Motion at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  12. Affected-to-Unaffected Isokinetic Deficit at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  13. Bilateral Grip Strength at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  14. Change in Affected-Hand Grip Strength From 4 to 12 Weeks

    Time frame: 4 and 12 weeks after closed reduction

    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.

  15. Change in Radial Inclination From Post-Reduction to 12 Weeks

    Time frame: Immediately after closed reduction and 12 weeks after closed reduction

    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.

  16. Change in Radial Height From Post-Reduction to 12 Weeks

    Time frame: Immediately after closed reduction and 12 weeks after closed reduction

    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.

  17. Change in Ulnar Variance From Post-Reduction to 12 Weeks

    Time frame: Immediately after closed reduction and 12 weeks after closed reduction

    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.

  18. Change in Volar Tilt From Post-Reduction to 12 Weeks

    Time frame: Immediately after closed reduction and 12 weeks after closed reduction

    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.

  19. Elbow or Shoulder Pain and Stiffness at Cast Removal

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  20. Patient-Rated Wrist and Hand Evaluation Total Score at 4 Weeks

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  21. Patient-Rated Wrist and Hand Evaluation Total Score at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  22. Quick Disabilities of the Arm, Shoulder and Hand Total Score at 4 Weeks

    Time frame: At cast removal, 4 weeks after closed reduction

    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.

  23. Quick Disabilities of the Arm, Shoulder and Hand Total Score at 12 Weeks

    Time frame: 12 weeks after closed reduction

    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.

  24. Number of Participants With Complications or Additional Treatment Through 12 Weeks

    Time frame: From closed reduction through 12 weeks after closed reduction

    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.

  25. Patient-Rated Wrist and Hand Evaluation Total Score at 5 Years

    Time frame: 5 years after closed reduction

    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.

  26. Quick Disabilities of the Arm, Shoulder and Hand Total Score at 5 Years

    Time frame: 5 years after closed reduction

    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.

  27. Treatment Satisfaction Score at 5 Years

    Time frame: 5 years after closed reduction

    Participants rated their satisfaction with the assigned casting treatment on a scale from 0 to 5. Higher scores indicate greater treatment satisfaction.

Other outcomes

  1. Contralateral Raw Isokinetic Peak Torque at the Initial Injury Assessment

    Time frame: At the initial injury assessment (Day 1)

    Cybex isokinetic dynamometry measured raw peak torque of the uninjured contralateral upper extremity during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded in newton-meters. Higher values indicate greater maximal isokinetic strength.

  2. Contralateral Isokinetic Peak Torque Normalized to Body Weight at the Initial Injury Assessment

    Time frame: At the initial injury assessment (Day 1)

    Peak torque of the uninjured contralateral upper extremity was measured using Cybex isokinetic dynamometry, normalized to body weight, and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Higher values indicate greater strength relative to body weight.

  3. Contralateral Raw Isokinetic Work per Repetition at the Initial Injury Assessment

    Time frame: At the initial injury assessment (Day 1)

    Cybex isokinetic dynamometry measured raw work per repetition of the uninjured contralateral upper extremity during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded in newton-meters. Higher values indicate greater work performed per repetition.

  4. Contralateral Isokinetic Work per Repetition Normalized to Body Weight at the Initial Injury Assessment

    Time frame: At the initial injury assessment (Day 1)

    Work per repetition of the uninjured contralateral upper extremity was measured using Cybex isokinetic dynamometry, normalized to body weight, and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Higher values indicate greater work capacity relative to body weight.

  5. Contralateral Isokinetic Range of Motion at the Initial Injury Assessment

    Time frame: At the initial injury assessment (Day 1)

    Range-of-motion values of the uninjured contralateral upper extremity were recorded in degrees during Cybex testing for elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation. Positive or negative values could be recorded according to the directional convention of the dynamometer.

  6. Contralateral Grip Strength at the Initial Injury Assessment

    Time frame: At the initial injury assessment (Day 1)

    Grip strength of the uninjured contralateral hand was measured in kilograms using a hand dynamometer. Three grip-strength trials were recorded. Higher values indicate greater grip strength.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Below-Elbow Versus Initial Above-Elbow Casting After Closed Reduction of Distal Radius Fractures: 12-Week Isokinetic and 5-Year Functional Outcomes of a Prospective Randomized Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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