Distal Radius FracturesNCT06255106
CT Analysis Comparing Cast and Three-Point Indexes in Distal Radius Fracture Care
An observational study of Distal Radius Fractures, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: To compare the cast index and three-point index measurements obtained using computed tomography (CT) with those acquired using conventional methods for treating distal radius fractures Design: A retrospective cohort study Setting: Level 1 trauma center Patients: One hundred and thirteen (45 men and 68… Read more about this study
- Who is it for?
- Ages 19 to 92 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- cast treatment
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 15 Jul 2023
- Phase
- Observational
- 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 19 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with distal radius fractures.
Who may be able to join
- Patients aged ≥18 years
- Diagnosed with distal radius fracture
- Treated with either cast or volar plate osteosynthesis were included in the study.
Who cannot join
- Patients with multiple fractures in the same upper extremity
- Those treated with dorsal plates or external fixators
- Individuals with open fractures
- Patients with known systemic or rheumatologic diseases
- Those with cervical disk problems
- Individuals lacking post-cast removal CT data
- Patients with incomplete medical records were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Computed Tomography Analysis of the Cast Index and Three-Point Index in Distal Radius Fracture Treatment
Objectives: To compare the cast index and three-point index measurements obtained using computed tomography (CT) with those acquired using conventional methods for treating distal radius fractures Design: A retrospective cohort study Setting: Level 1 trauma center Patients: One hundred and thirteen (45 men and 68 women) patients with distal radius fractures Interventions: Patients with distal radius fractures were retrospectively analyzed and received either conservative cast treatment or surgical intervention through open reduction and internal fixation between 2016 and 2022.
Main outcome measurements: The study evaluated the cast index and three-point index in the cast-treated group and their effectiveness using the Sarmiento index. Furthermore, radial height, volar tilt, and radial inclination were compared between the surgically treated and cast-treated groups.
- Conditions
- Distal Radius Fractures
- Being tested
- cast treatment
- Keywords
- distal radius fracture, cast index, three point index, computed tomography
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cast treatmentOther
Also called Open reduction volar plate fixation
Surgical intervention vs cast treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1, consisting of individuals treated with a cast Receives: Other: cast treatment | |
| Group 2 | Group 2, comprising those who underwent surgical intervention (Open reduction volar plate fixation. Receives: Other: cast treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial height
Radiologic outcome measurement
Measured: 2 weeks
Radial İnclination
Radiologic outcome measurement
Measured: 2 weeks
Volar tilt
Radiologic outcome measurement
Measured: 2 weeks
Sarmiento radiological score
success of cast treatment
Measured: 2 weeks
Secondary outcomes (2)
Axial Cast İndex
Cast index measure in axial plane CT
Measured: 2 weeks
Three point index CT
Three point index measure in CT
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Feb 2022
- Primary completion10 May 2023
- Study completion15 Jul 2023
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 FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Samet Gokceoglu, Istanbul University
- Investigators
- Yaşar Samet Gökçeoğlu, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255106
- Sponsor's protocol ID
- DistalRadiuscast
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song J, Yu AX, Li ZH. Comparison of conservative and operative treatment for distal radius fracture: a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2015 Oct 15;8(10):17023-35. eCollection 2015.
PubMed 26770293Kahraman HC, Sibar K, Alemdaroglu KB, Subasi IO, Gokgoz MB. Is three-point index reliable in the follow-up of the distal radius metaphys fractures in the pediatric age group? J Pediatr Orthop B. 2023 Jul 1;32(4):369-377. doi: 10.1097/BPB.0000000000001032. Epub 2022 Nov 14.
PubMed 36377954Owen RA, Melton LJ 3rd, Johnson KA, Ilstrup DM, Riggs BL. Incidence of Colles' fracture in a North American community. Am J Public Health. 1982 Jun;72(6):605-7. doi: 10.2105/ajph.72.6.605.
PubMed 7072880Alemdaroglu KB, Iltar S, Aydogan NH, Say F, Kilinc CY, Tiftikci U. Three-point index in predicting redisplacement of extra-articular distal radial fractures in adults. Injury. 2010 Feb;41(2):197-203. doi: 10.1016/j.injury.2009.08.021. Epub 2009 Sep 26.
PubMed 19782974Hosseinzadeh P, Olson D, Eads R, Jaglowicz A, Goldfarb CA, Riley SA. Radiologic Evaluation of the Distal Radius Indices in Early And Late Childhood. Iowa Orthop J. 2018;38:137-140.
PubMed 30104936
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Computed Tomography Analysis of the Cast Index and Three-Point Index in Distal Radius Fracture Treatment
- ClinicalTrials.gov ID
- NCT06255106
- Acronym / sponsor ID
- DistalRadiuscast
- Conditions
- Distal Radius Fractures
- Keywords
- distal radius fracture, cast index, three point index, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 12 Feb 2024 (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.
Objectives: To compare the cast index and three-point index measurements obtained using computed tomography (CT) with those acquired using conventional methods for treating distal radius fractures Design: A retrospective cohort study Setting: Level 1 trauma center Patients: One hundred and thirteen (45 men and 68 women) patients with distal radius fractures Interventions: Patients with distal radius fractures were retrospectively analyzed and received either conservative cast treatment or surgical intervention through open reduction and internal fixation between 2016 and 2022.
Main outcome measurements: The study evaluated the cast index and three-point index in the cast-treated group and their effectiveness using the Sarmiento index. Furthermore, radial height, volar tilt, and radial inclination were compared between the surgically treated and cast-treated groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: cast treatmentGroup 1, consisting of individuals treated with a cast |
| Group 2 | – | Other: cast treatmentGroup 2, comprising those who underwent surgical intervention (Open reduction volar plate fixation. |
Who may qualify
- Ages
- 19 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with distal radius fractures.
Key inclusion criteria (3 listed)
- Patients aged ≥18 years
- Diagnosed with distal radius fracture
- Treated with either cast or volar plate osteosynthesis were included in the study.
Key exclusion criteria (7 listed)
- Patients with multiple fractures in the same upper extremity
- Those treated with dorsal plates or external fixators
- Individuals with open fractures
- Patients with known systemic or rheumatologic diseases
- Those with cervical disk problems
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 |
|---|---|---|
| cast treatmentAlso: Open reduction volar plate fixationSurgical intervention vs cast treatment | Other | Group 1, Group 2 |
Primary outcome
Radial height
Time frame: 2 weeks
Radiologic outcome measurement
Radial İnclination
Time frame: 2 weeks
Radiologic outcome measurement
Volar tilt
Time frame: 2 weeks
Radiologic outcome measurement
Sarmiento radiological score
Time frame: 2 weeks
success of cast treatment
2 secondary outcomes
Axial Cast İndex
Time frame: 2 weeks
Three point index CT
Time frame: 2 weeks
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 12 Feb 2024.
- Background: PubMed 26770293Song J, Yu AX, Li ZH. Comparison of conservative and operative treatment for distal radius fracture: a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2015 Oct 15;8(10):17023-35. eCollection 2015.
- Background: PubMed 36377954Kahraman HC, Sibar K, Alemdaroglu KB, Subasi IO, Gokgoz MB. Is three-point index reliable in the follow-up of the distal radius metaphys fractures in the pediatric age group? J Pediatr Orthop B. 2023 Jul 1;32(4):369-377. doi: 10.1097/BPB.0000000000001032. Epub 2022 Nov 14.
- Results publication: PubMed 7072880Owen RA, Melton LJ 3rd, Johnson KA, Ilstrup DM, Riggs BL. Incidence of Colles' fracture in a North American community. Am J Public Health. 1982 Jun;72(6):605-7. doi: 10.2105/ajph.72.6.605.
- Results publication: PubMed 19782974Alemdaroglu KB, Iltar S, Aydogan NH, Say F, Kilinc CY, Tiftikci U. Three-point index in predicting redisplacement of extra-articular distal radial fractures in adults. Injury. 2010 Feb;41(2):197-203. doi: 10.1016/j.injury.2009.08.021. Epub 2009 Sep 26.
- Results publication: PubMed 30104936Hosseinzadeh P, Olson D, Eads R, Jaglowicz A, Goldfarb CA, Riley SA. Radiologic Evaluation of the Distal Radius Indices in Early And Late Childhood. Iowa Orthop J. 2018;38:137-140.
- Individual participant dataSharing planned: No
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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.
Yaşar Samet Gökçeoğlu, MD 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?
An observational study of Distal Radius Fractures, 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 7 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 12 Feb 2024. 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?
Radial height (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 NCT06255106, 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 12 Feb 2024.