Scaphoid FractureNCT04892862
Dorsal and Volar Surgeries Preferred in Scaphoid Pseudorthrosis Comparison of Effects on Kinematics
A study testing SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACH and SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACH in people with Scaphoid Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Our aim is to objectively analyze the effects of the non-vascularized autograft taken from the radius and the dorsal and volar surgical approach on the preop and postop wrist kinematics and the movements we use frequently in daily life, and to present the results. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Scaphoid Fracture
- What is being tested?
- SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACH and SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACH
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Jul 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- healty male
- without any chronic systemic dissease
- must not have drug addiction
- must not have surgical prosedure on affected upper extremity before
- patient shouldnt have VISI DISI DEFOMİTY and radiocarpal arthrosis on affected wrist
- there must be minimum 1 year maximum 10 year between trauma and surgery
Who cannot join
- Criteria:having vascular and neurological spaces in the same extremity without previous trauma or surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Our aim is to objectively analyze the effects of the non-vascularized autograft taken from the radius and the dorsal and volar surgical approach on the preop and postop wrist kinematics and the movements we use frequently in daily life, and to present the results.
Read the detailed description
At least 23 working male patients between the ages of 20-50 who do not have active additional diseases will be included in the study, and those who have not previously had trauma or surgical intervention on the same extremity, and who do not have vascular and neurological fields, These patients will be followed-up at the itf orthopedic clinic and the medical faculty orthopedics clinic. their patients will be After the preop and postop union is provided to the patients who will be divided into 2 groups of at least 10 people (in the 12th month postop), the wrist motion analysis will be performed with the XSENS MTw Awinda 17 sensor full body motion capture system in the Bahçeşehir University biomechanics laboratory (separate on the healthy side). In addition to the rum, 5 movements such as personal wc cleaning, drinking coffee from the cup will be stimulated by looking at the healthy side.
- Conditions
- Scaphoid Fracture
- Being tested
- SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACH, SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACHProcedure or surgery
ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . LISTER TUBERCULA WITH 3 CM PROXIMAL AND 3 CM DISTAL IN INCISION MADE UNDER THE SKIN. 2,3 EXTENSOR COMPARTMENTS RADIAL 4. THE EXTENSON COMPARTMENT IS EARTHED TO ULNAR A AND THE WRIST JOINT CAPSULE IS REACHED. THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision ON DISTAL UNDER RADIUS metaphyseal area of 2CM. 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures.
SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACHProcedure or surgery
ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . İNCİSİON STARTS 2 CM RADİAL TO SCAPHOİD TUBERCULE EXTENTS ITS 3 CM PROXİMAL . AFTER PASİNG SUBCUTANEOUS TİSSUE , FCR AND RADİAL ARTERY ARE İDENTİFİED AND DİVİDED SEPERATLY THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision WİTH PASSİNG PRONATOR QUADRATUS MUSCLE , ON DISTAL UNDER 2 CENTİMETER OF RADIUS metaphyseal area . 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures.
| Study group | Role | What they receive |
|---|---|---|
| dorsal surgical approach | Active comparator | dorsal surgical approach Receives: Procedure: SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACH |
| volar surgical approach | Active comparator | volar surgical approach Receives: Procedure: SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHANGES İN WRİST RANGE OF MOTİON
measure wrist range of motion with goniometer
Measured: preoperation , postop 3. week, 6. week, 3.month, 6. month and avarage of first year
assess bone union
assesing union on wrist antero-posterior/ lateral x-rays, by identification of trabeculae crossing the fracture line or sclerosis at the fracture line
Measured: 3 weeks to 3 months post-op
Secondary outcomes (3)
DASH score
Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score. The DASH questionnaire is used as an indicator of the impact of an impairment on the level and type of disability we expect decrease after operation
Measured: preoperation , avarage of first year after operation
HAND MAYO SCORE
Mayo Wrist Score -- OrthoToolKit Scores range from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition. Original Literature: Cooney, W. P., et al. "Difficult wrist fractures.
Measured: preoperation , avarage of first year after operation
VAS SCORES
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: preoperation , avarage of first year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Mar 2020
- Primary completion1 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid FractureStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- PROSPECTIVE RANDOMİZE CLİNİCAL TRİAL
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Serhat Aydın, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892862
- Sponsor's protocol ID
- 2020/779
- Status last verified
- Aug 2022
- First submitted
- 23 Mar 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsal and Volar Surgeries Preferred in Scaphoid Pseudorthrosis Comparison of Effects on Kinematics
- ClinicalTrials.gov ID
- NCT04892862
- Acronym / sponsor ID
- 2020/779
- Conditions
- Scaphoid Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 May 2021 (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.
Our aim is to objectively analyze the effects of the non-vascularized autograft taken from the radius and the dorsal and volar surgical approach on the preop and postop wrist kinematics and the movements we use frequently in daily life, and to present the results.
Detailed description
At least 23 working male patients between the ages of 20-50 who do not have active additional diseases will be included in the study, and those who have not previously had trauma or surgical intervention on the same extremity, and who do not have vascular and neurological fields, These patients will be followed-up at the itf orthopedic clinic and the medical faculty orthopedics clinic. their patients will be After the preop and postop union is provided to the patients who will be divided into 2 groups of at least 10 people (in the 12th month postop), the wrist motion analysis will be performed with the XSENS MTw Awinda 17 sensor full body motion capture system in the Bahçeşehir University biomechanics laboratory (separate on the healthy side). In addition to the rum, 5 movements such as personal wc cleaning, drinking coffee from the cup will be stimulated by looking at the healthy side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PROSPECTIVE RANDOMİZE CLİNİCAL TRİAL
| Arm | Type | Receives |
|---|---|---|
| dorsal surgical approach | Active comparator | Procedure: SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACHdorsal surgical approach |
| volar surgical approach | Active comparator | Procedure: SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACHvolar surgical approach |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healty male
- without any chronic systemic dissease
- must not have drug addiction
- must not have surgical prosedure on affected upper extremity before
- patient shouldnt have VISI DISI DEFOMİTY and radiocarpal arthrosis on affected wrist
Key exclusion criteria (1 listed)
- Criteria:having vascular and neurological spaces in the same extremity without previous trauma or surgical intervention
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 |
|---|---|---|
| SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACHON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . LISTER TUBERCULA WITH 3 CM PROXIMAL AND 3 CM DISTAL IN INCISION MADE UNDER THE SKIN. 2,3 EXTENSOR COMPARTMENTS RADIAL 4. THE EXTENSON COMPARTMENT IS EARTHED TO ULNAR A AND THE WRIST JOINT CAPSULE IS REACHED. THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision ON DISTAL UNDER RADIUS metaphyseal area of 2CM. 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures. | Procedure or surgery | dorsal surgical approach |
| SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACHON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . İNCİSİON STARTS 2 CM RADİAL TO SCAPHOİD TUBERCULE EXTENTS ITS 3 CM PROXİMAL . AFTER PASİNG SUBCUTANEOUS TİSSUE , FCR AND RADİAL ARTERY ARE İDENTİFİED AND DİVİDED SEPERATLY THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision WİTH PASSİNG PRONATOR QUADRATUS MUSCLE , ON DISTAL UNDER 2 CENTİMETER OF RADIUS metaphyseal area . 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures. | Procedure or surgery | volar surgical approach |
Primary outcome
CHANGES İN WRİST RANGE OF MOTİON
Time frame: preoperation , postop 3. week, 6. week, 3.month, 6. month and avarage of first year
measure wrist range of motion with goniometer
assess bone union
Time frame: 3 weeks to 3 months post-op
assesing union on wrist antero-posterior/ lateral x-rays, by identification of trabeculae crossing the fracture line or sclerosis at the fracture line
3 secondary outcomes
DASH score
Time frame: preoperation , avarage of first year after operation
HAND MAYO SCORE
Time frame: preoperation , avarage of first year after operation
VAS SCORES
Time frame: preoperation , avarage of first year after operation
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 4 Nov 2026.
- 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.
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 SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACH and SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACH in people with Scaphoid 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 6 inclusion and 1 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 4 Nov 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?
CHANGES İN WRİST RANGE OF MOTİON (time frame: preoperation , postop 3. week, 6. week, 3.month, 6. month and avarage of first year). The study lists 2 primary outcomes in all. 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 4 Nov 2026.