Distal Radius FractureNCT07704879
Below-Elbow Versus Initial Above-Elbow Casting for Distal Radius Fractures
A study testing Below-Elbow Cast Immobilization and Initial Above-Elbow Cast Followed by Below-Elbow Cast in people with Distal Radius Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Below-Elbow Cast Immobilization and Initial Above-Elbow Cast Followed by Below-Elbow Cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2020to 14 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
Istanbul, 34093
About this study
Official 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
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Distal Radius Fracture
- Being tested
- Below-Elbow Cast Immobilization, Initial Above-Elbow Cast Followed by Below-Elbow Cast
- Keywords
- Below-elbow cast, Initial above-elbow cast, Short-arm cast, Long-arm cast, Closed reduction, Cast immobilization, Nonoperative treatment, Isokinetic dynamometry, Grip strength, Reduction loss, Five-year follow-up, Wrist fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Below-Elbow Cast ImmobilizationProcedure or surgery
Also called Short-Arm Cast Immobilization
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.
Initial Above-Elbow Cast Followed by Below-Elbow CastProcedure or surgery
Also called Initial Long-Arm Cast Followed by Short-Arm Cast
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.
| Study group | Role | What they receive |
|---|---|---|
| Below-Elbow Cast | Experimental | After nonoperative treatment was determined to be appropriate and closed reduction was completed, participants received a below-elbow cast. Cast immobilization continued for 4 weeks, after which the cast was removed and splinting and rehabilitation were started. Receives: Procedure: Below-Elbow Cast Immobilization |
| Initial Above-Elbow Cast | Active comparator | After nonoperative treatment was determined to be appropriate and closed reduction was completed, participants received an above-elbow cast. At 2 weeks, the cast was converted to a below-elbow cast. All cast immobilization ended at 4 weeks, followed by splinting and rehabilitation. Receives: Procedure: Initial Above-Elbow Cast Followed by Below-Elbow Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after closed reduction
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years after closed reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start2 Jul 2020
- Primary completion20 Jun 2022
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the treating team established that nonoperative treatment was appropriate, participants underwent closed reduction and were randomized in parallel to below-elbow casting or initial above-elbow casting. In the initial above-elbow casting group, the cast was converted to a below-elbow cast at 2 weeks. Cast immobilization ended at 4 weeks in both groups, followed by splinting and rehabilitation.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Sukru Kendirci, Istanbul University
- Investigators
- Alper Ş. Kendirci, M.D., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704879
- Sponsor's protocol ID
- 2020/882
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share de-identified individual participant data with other researchers. No prospective IPD-sharing framework, repository, or data-access process was established for this single-center study. Participant-level data will therefore not be made available for secondary research; study findings will be reported in aggregate form.
Publications
Chaudhry YP, Morway GR, Papadelis EA, Doerr NA, Graf KW, Mashru RP, Dolch HJ. Comparison of Short-Arm Immobilization and Long-Arm Immobilization in Conservatively Managed Distal Radius Fractures: A Meta-Analysis and Systematic Review. Cureus. 2024 Mar 8;16(3):e55813. doi: 10.7759/cureus.55813. eCollection 2024 Mar.
PubMed 38590464Okamura A, de Moraes VY, Neto JR, Tamaoki MJ, Faloppa F, Belloti JC. No benefit for elbow blocking on conservative treatment of distal radius fractures: A 6-month randomized controlled trial. PLoS One. 2021 Jun 10;16(6):e0252667. doi: 10.1371/journal.pone.0252667. eCollection 2021.
PubMed 34111160Caruso G, Tonon F, Gildone A, Andreotti M, Altavilla R, Valentini A, Valpiani G, Massari L. Below-elbow or above-elbow cast for conservative treatment of extra-articular distal radius fractures with dorsal displacement: a prospective randomized trial. J Orthop Surg Res. 2019 Dec 30;14(1):477. doi: 10.1186/s13018-019-1530-1.
PubMed 31888682Dib G, Maluta T, Cengarle M, Bernasconi A, Marconato G, Corain M, Magnan B. Short arm cast is as effective as long arm cast in maintaining distal radius fracture reduction: Results of the SLA-VER noninferiority trial. World J Orthop. 2022 Sep 18;13(9):802-811. doi: 10.5312/wjo.v13.i9.802. eCollection 2022 Sep 18.
PubMed 36189333Park MJ, Kim JP, Lee HI, Lim TK, Jung HS, Lee JS. Is a short arm cast appropriate for stable distal radius fractures in patients older than 55 years? A randomized prospective multicentre study. J Hand Surg Eur Vol. 2017 Jun;42(5):487-492. doi: 10.1177/1753193417690464. Epub 2017 Mar 1.
PubMed 28490225
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07704879
- Acronym / sponsor ID
- 2020/882
- Conditions
- Distal Radius Fracture
- Keywords
- Below-elbow cast, Initial above-elbow cast, Short-arm cast, Long-arm cast, Closed reduction, Cast immobilization, Nonoperative treatment, Isokinetic dynamometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After the treating team established that nonoperative treatment was appropriate, participants underwent closed reduction and were randomized in parallel to below-elbow casting or initial above-elbow casting. In the initial above-elbow casting group, the cast was converted to a below-elbow cast at 2 weeks. Cast immobilization ended at 4 weeks in both groups, followed by splinting and rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Below-Elbow Cast | Experimental | Procedure: Below-Elbow Cast ImmobilizationAfter nonoperative treatment was determined to be appropriate and closed reduction was completed, participants received a below-elbow cast. Cast immobilization continued for 4 weeks, after which the cast was removed and splinting and rehabilitation were started. |
| Initial Above-Elbow Cast | Active comparator | Procedure: Initial Above-Elbow Cast Followed by Below-Elbow CastAfter nonoperative treatment was determined to be appropriate and closed reduction was completed, participants received an above-elbow cast. At 2 weeks, the cast was converted to a below-elbow cast. All cast immobilization ended at 4 weeks, followed by splinting and rehabilitation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Below-Elbow Cast ImmobilizationAlso: Short-Arm Cast ImmobilizationA 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. | Procedure or surgery | Below-Elbow Cast |
| Initial Above-Elbow Cast Followed by Below-Elbow CastAlso: Initial Long-Arm Cast Followed by Short-Arm CastAn 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. | Procedure or surgery | Initial Above-Elbow Cast |
Primary outcome
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.
27 secondary outcomes
Raw Isokinetic Peak Torque at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Raw Isokinetic Peak Torque at 12 Weeks
Time frame: 12 weeks after closed reduction
Isokinetic Peak Torque Normalized to Body Weight at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Raw Isokinetic Work per Repetition at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Isokinetic Range of Motion at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Affected-to-Unaffected Isokinetic Deficit at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Bilateral Grip Strength at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Raw Isokinetic Work per Repetition at 12 Weeks
Time frame: 12 weeks after closed reduction
Isokinetic Work per Repetition Normalized to Body Weight at 12 Weeks
Time frame: 12 weeks after closed reduction
Isokinetic Range of Motion at 12 Weeks
Time frame: 12 weeks after closed reduction
Affected-to-Unaffected Isokinetic Deficit at 12 Weeks
Time frame: 12 weeks after closed reduction
Bilateral Grip Strength at 12 Weeks
Time frame: 12 weeks after closed reduction
Change in Affected-Hand Grip Strength From 4 to 12 Weeks
Time frame: 4 and 12 weeks after closed reduction
Change in Radial Inclination From Post-Reduction to 12 Weeks
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Change in Radial Height From Post-Reduction to 12 Weeks
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Change in Ulnar Variance From Post-Reduction to 12 Weeks
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Change in Volar Tilt From Post-Reduction to 12 Weeks
Time frame: Immediately after closed reduction and 12 weeks after closed reduction
Elbow or Shoulder Pain and Stiffness at Cast Removal
Time frame: At cast removal, 4 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 4 Weeks
Time frame: At cast removal, 4 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 12 Weeks
Time frame: 12 weeks after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 4 Weeks
Time frame: At cast removal, 4 weeks after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 12 Weeks
Time frame: 12 weeks after closed reduction
Number of Participants With Complications or Additional Treatment Through 12 Weeks
Time frame: From closed reduction through 12 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 5 Years
Time frame: 5 years after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 5 Years
Time frame: 5 years after closed reduction
Treatment Satisfaction Score at 5 Years
Time frame: 5 years after closed reduction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 38590464Chaudhry YP, Morway GR, Papadelis EA, Doerr NA, Graf KW, Mashru RP, Dolch HJ. Comparison of Short-Arm Immobilization and Long-Arm Immobilization in Conservatively Managed Distal Radius Fractures: A Meta-Analysis and Systematic Review. Cureus. 2024 Mar 8;16(3):e55813. doi: 10.7759/cureus.55813. eCollection 2024 Mar.
- Background: PubMed 34111160Okamura A, de Moraes VY, Neto JR, Tamaoki MJ, Faloppa F, Belloti JC. No benefit for elbow blocking on conservative treatment of distal radius fractures: A 6-month randomized controlled trial. PLoS One. 2021 Jun 10;16(6):e0252667. doi: 10.1371/journal.pone.0252667. eCollection 2021.
- Background: PubMed 31888682Caruso G, Tonon F, Gildone A, Andreotti M, Altavilla R, Valentini A, Valpiani G, Massari L. Below-elbow or above-elbow cast for conservative treatment of extra-articular distal radius fractures with dorsal displacement: a prospective randomized trial. J Orthop Surg Res. 2019 Dec 30;14(1):477. doi: 10.1186/s13018-019-1530-1.
- Background: PubMed 36189333Dib G, Maluta T, Cengarle M, Bernasconi A, Marconato G, Corain M, Magnan B. Short arm cast is as effective as long arm cast in maintaining distal radius fracture reduction: Results of the SLA-VER noninferiority trial. World J Orthop. 2022 Sep 18;13(9):802-811. doi: 10.5312/wjo.v13.i9.802. eCollection 2022 Sep 18.
- Background: PubMed 28490225Park MJ, Kim JP, Lee HI, Lim TK, Jung HS, Lee JS. Is a short arm cast appropriate for stable distal radius fractures in patients older than 55 years? A randomized prospective multicentre study. J Hand Surg Eur Vol. 2017 Jun;42(5):487-492. doi: 10.1177/1753193417690464. Epub 2017 Mar 1.
- Individual participant dataSharing planned: No. There is no plan to share de-identified individual participant data with other researchers. No prospective IPD-sharing framework, repository, or data-access process was established for this single-center study. Participant-level data will therefore not be made available for secondary research; study findings will be reported in aggregate form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alper Ş. Kendirci, M.D. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Below-Elbow Cast Immobilization and Initial Above-Elbow Cast Followed by Below-Elbow Cast in people with Distal Radius Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks (time frame: 12 weeks after closed reduction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07704879, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.