UnionNCT07039695
Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate
A study testing Volar buttress plate and Herbert screw in people with Union and Scaphoid, run by Helwan University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the short-term results of treating non-united scaphoid waist fractures with a humpback deformity by graft and internal fixation using a volar buttress plate versus the use of a Herbert screw. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Union, Scaphoid, Non-Union Fracture
- What is being tested?
- Volar buttress plate and Herbert screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Jun 2022
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of a patient is between 20 years to 50 years.
- Non-union or delayed union scaphoid wrist fracture (more than 3 months).
- Closed fracture.
- Patients without previous scaphoid surgery.
- Patients without abnormal renal and/or liver functions.
- Patients without hypocalcemia and/or vitamin D3 deficiency.
Who cannot join
- Open fracture.
- Patients with proximal or distal fracture of the scaphoid.
- Patients with avascular necrosis of scaphoid.
- Patients with mid-carpal arthritis or pan-carpal arthritis.
- Patients with carpal instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate
This study aimed to evaluate the short-term results of treating non-united scaphoid waist fractures with a humpback deformity by graft and internal fixation using a volar buttress plate versus the use of a Herbert screw.
Read the detailed description
Scaphoid fracture is the most common fracture, accounting for roughly 60% of the total carpal bone fractures and 11 % of all hand fractures.
Nonunion occurs in approximately 5% to 25 % of scaphoid fractures. The scaphoid nonunion will collapse into a humpback deformity, and the lunate, together with the proximal pole, into a dorsal intercalated segment instability, which might end in an advanced carpal collapse.
A scaphoid screw acts to prevent bending at the fracture site with three-point fixation within the cancellous bone of the scaphoid. The proximal and distal points of purchase are achieved by the capture of the screw threads in the cancellous bone of the proximal and distal poles of the scaphoid. The third point occurs within the cancellous bone of the scaphoid waist.
- Conditions
- Union, Scaphoid, Non-Union Fracture, Herbert Screw, Volar Buttress Plate
- Being tested
- Volar buttress plate, Herbert screw
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar buttress plateProcedure or surgery
Patients will be treated by a volar buttress plate.
Herbert screwProcedure or surgery
Patients will be treated by Herbert screw.
| Study group | Role | What they receive |
|---|---|---|
| Volar buttress plate group | Experimental | Patients will be treated by a volar buttress plate. Receives: Procedure: Volar buttress plate |
| Herbert screw group | Experimental | Patients will be treated by Herbert screw. Receives: Procedure: Herbert screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Wrist Score
The Mayo Wrist Score is a fast and simple tool comprising four questions that assess pain intensity, wrist function, range of motion, and grip strength. Mayo Wrist Score ranges from 0 to 100. Scores of 90-100 are considered excellent, 80-90 good, 60-80 satisfactory, and below 60 poor.
Measured: 3 months post-procedure
Secondary outcomes (1)
Disabilities of the Arm, Shoulder and Hand (DASH) score
The Disabilities of the Arm, Shoulder and Hand (DASH) is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. The score is calculated on a scale score ranging from 0 (no disability) to 100 (most severe disability).
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Mar 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UnionStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Karam Abed El-Aleem Mohammed, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039695
- Sponsor's protocol ID
- 10-2020
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate
- ClinicalTrials.gov ID
- NCT07039695
- Acronym / sponsor ID
- 10-2020
- Conditions
- Union, Scaphoid, Non-Union Fracture, Herbert Screw, Volar Buttress Plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 26 Jun 2025 (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.
This study aimed to evaluate the short-term results of treating non-united scaphoid waist fractures with a humpback deformity by graft and internal fixation using a volar buttress plate versus the use of a Herbert screw.
Detailed description
Scaphoid fracture is the most common fracture, accounting for roughly 60% of the total carpal bone fractures and 11 % of all hand fractures.
Nonunion occurs in approximately 5% to 25 % of scaphoid fractures. The scaphoid nonunion will collapse into a humpback deformity, and the lunate, together with the proximal pole, into a dorsal intercalated segment instability, which might end in an advanced carpal collapse.
A scaphoid screw acts to prevent bending at the fracture site with three-point fixation within the cancellous bone of the scaphoid. The proximal and distal points of purchase are achieved by the capture of the screw threads in the cancellous bone of the proximal and distal poles of the scaphoid. The third point occurs within the cancellous bone of the scaphoid waist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar buttress plate group | Experimental | Procedure: Volar buttress platePatients will be treated by a volar buttress plate. |
| Herbert screw group | Experimental | Procedure: Herbert screwPatients will be treated by Herbert screw. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age of a patient is between 20 years to 50 years.
- Non-union or delayed union scaphoid wrist fracture (more than 3 months).
- Closed fracture.
- Patients without previous scaphoid surgery.
- Patients without abnormal renal and/or liver functions.
Key exclusion criteria (5 listed)
- Open fracture.
- Patients with proximal or distal fracture of the scaphoid.
- Patients with avascular necrosis of scaphoid.
- Patients with mid-carpal arthritis or pan-carpal arthritis.
- Patients with carpal instability.
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 |
|---|---|---|
| Volar buttress platePatients will be treated by a volar buttress plate. | Procedure or surgery | Volar buttress plate group |
| Herbert screwPatients will be treated by Herbert screw. | Procedure or surgery | Herbert screw group |
Primary outcome
Mayo Wrist Score
Time frame: 3 months post-procedure
The Mayo Wrist Score is a fast and simple tool comprising four questions that assess pain intensity, wrist function, range of motion, and grip strength. Mayo Wrist Score ranges from 0 to 100. Scores of 90-100 are considered excellent, 80-90 good, 60-80 satisfactory, and below 60 poor.
1 secondary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: 3 months post-procedure
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 26 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar buttress plate and Herbert screw in people with Union and Scaphoid, run by Helwan University at 1 site in Egypt.
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 6 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 26 Jun 2025. 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 Egypt. 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?
Mayo Wrist Score (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.