Scaphoid Fracture Non UnionNCT07320404
Arthroscopic Scaphoid Grafting Versus Open Grafting in Scaphoid Non Union
A study testing Arthroscopic grafting and k wires fixation and open scaphoid grafting with K wires fixation in people with Scaphoid Fracture Non Union, run by Ain Shams University at 1 site in Egypt.
Trial summary
the investigators compare the arthroscopic grafting technique with the traditional open technique in th treatment of scaphoid non union as regards the union rate, time to union and functional outcomes to provide the best intervention to the patient Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Scaphoid Fracture Non Union
- What is being tested?
- Arthroscopic grafting and k wires fixation and open scaphoid grafting with K wires fixation
- 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
- 19 Sep 2019to 10 Mar 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- scaphoid non-union cases
- 16 years or older
- males or females
- independent from chronicity or non-union location and the investigators defined the non union as failure to reach scaphoid union up to 6 months
Who cannot join
- .Revision scaphoid non-union cases.
- Previously operated wrist for any other pathology
- Avascular necrosis (AVN) confirmed by intraoperative inspection.
- Scaphoid non-union advanced collapse (SNAC) stage 2 and higher.
- Any associated wrist pathology that required separate treatment surgical approach.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Scaphoid Bone Graft Combined With Percutaneous Fixation Versus Open Scaphoid Fixation With Non Vascularized Graft in Scaphoid Non-union
the investigators compare the arthroscopic grafting technique with the traditional open technique in th treatment of scaphoid non union as regards the union rate, time to union and functional outcomes to provide the best intervention to the patient
Read the detailed description
The treatment of scaphoid non union has no gold standard technique so in this study the investigators try to compare the arthroscopic and the open grafting techniques to determine the better technique to achieve union, time to union and the better functional outcomes including wrist range of motion and grip strength as a primary outcome and the secondary outcomes are the operative time, the complications and radiological correction of the hum-back deformity if present.
- Conditions
- Scaphoid Fracture Non Union
- Being tested
- Arthroscopic grafting and k wires fixation, open scaphoid grafting with K wires fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic grafting and k wires fixationProcedure or surgery
Arthroscopic midrcarpal scaphoid non union debridment and iliac cancellous bone grafting with K wires fixation
open scaphoid grafting with K wires fixationProcedure or surgery
open surgical volar or dorsal scaphoid non union site debridment and application of iliac bone graft and K wires fixation
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic A group | Experimental | arthroscopic bone grafting combined with percutaneous K wires fixation for scaphoid non union patients Receives: Procedure: Arthroscopic grafting and k wires fixation |
| open O group | Experimental | open volar or dorsal scaphoid grafting with K wires fixation for scaphoid non union patients Receives: Procedure: open scaphoid grafting with K wires fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
union rate
percentage of patients in each arm that achieve bony union
Measured: 6 months
time to union
the time that patient take to achieve bony union
Measured: 6 to 24 weeks
wrist flexion and extension
flexion and extension range of motion
Measured: preoperative, at 6 months and at 24 months
wrist radial and ulnar deviation
radial and ulnar deviation range of motion
Measured: preoperative, at 6 months and at 24 months
grip strength
the power of hand grip measured by dynamometer
Measured: preoperative , at 6 months and at 24 months
The disability of arm, shoulder and hand score (DASH score)
a questionnaire to assess upper limb function from 0 to 100 where the lower the score means better outcome
Measured: preoperative , at 6 months and at 24 months
The Mayo modified wrist score
A functional score that depends on the patients function and examination from 0 to 100 and the higher the score the higher the outcome
Measured: preoperative, at 6 months and at 24 months
Secondary outcomes (3)
complications
Measured: 2 years post operative
Degree of scaphoid hump back deformity correction
Radiological parameter thorough scapholunate angle
Measured: post operative after bony union up to 1 year
Operative time
the duration of each operation
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start19 Sep 2019
- Primary completion23 Dec 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scaphoid Fracture Non UnionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 2 groups one with the arthroscopic grafting combined with percutaneous fixation, the second with opend grafting and fixation by K wires.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed El-Mahy, prof., Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320404
- Sponsor's protocol ID
- FAMSU MD 288/2019
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jegal M, Kim JS, Kim JP. Arthroscopic Management of Scaphoid Nonunions. Hand Surg. 2015;20(2):215-21. doi: 10.1142/S0218810415400031.
PubMed 26051763Munk B, Larsen CF. Bone grafting the scaphoid nonunion: a systematic review of 147 publications including 5,246 cases of scaphoid nonunion. Acta Orthop Scand. 2004 Oct;75(5):618-29. doi: 10.1080/00016470410001529.
PubMed 15513497
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Scaphoid Bone Graft Combined With Percutaneous Fixation Versus Open Scaphoid Fixation With Non Vascularized Graft in Scaphoid Non-union
- ClinicalTrials.gov ID
- NCT07320404
- Acronym / sponsor ID
- FAMSU MD 288/2019
- Conditions
- Scaphoid Fracture Non Union
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 6 Jan 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 investigators compare the arthroscopic grafting technique with the traditional open technique in th treatment of scaphoid non union as regards the union rate, time to union and functional outcomes to provide the best intervention to the patient
Detailed description
The treatment of scaphoid non union has no gold standard technique so in this study the investigators try to compare the arthroscopic and the open grafting techniques to determine the better technique to achieve union, time to union and the better functional outcomes including wrist range of motion and grip strength as a primary outcome and the secondary outcomes are the operative time, the complications and radiological correction of the hum-back deformity if present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups one with the arthroscopic grafting combined with percutaneous fixation, the second with opend grafting and fixation by K wires.
| Arm | Type | Receives |
|---|---|---|
| arthroscopic A group | Experimental | Procedure: Arthroscopic grafting and k wires fixationarthroscopic bone grafting combined with percutaneous K wires fixation for scaphoid non union patients |
| open O group | Experimental | Procedure: open scaphoid grafting with K wires fixationopen volar or dorsal scaphoid grafting with K wires fixation for scaphoid non union patients |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- scaphoid non-union cases
- 16 years or older
- males or females
- independent from chronicity or non-union location and the investigators defined the non union as failure to reach scaphoid union up to 6 months
Key exclusion criteria (5 listed)
- .Revision scaphoid non-union cases.
- Previously operated wrist for any other pathology
- Avascular necrosis (AVN) confirmed by intraoperative inspection.
- Scaphoid non-union advanced collapse (SNAC) stage 2 and higher.
- Any associated wrist pathology that required separate treatment surgical approach.
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 |
|---|---|---|
| Arthroscopic grafting and k wires fixationArthroscopic midrcarpal scaphoid non union debridment and iliac cancellous bone grafting with K wires fixation | Procedure or surgery | arthroscopic A group |
| open scaphoid grafting with K wires fixationopen surgical volar or dorsal scaphoid non union site debridment and application of iliac bone graft and K wires fixation | Procedure or surgery | open O group |
Primary outcome
union rate
Time frame: 6 months
percentage of patients in each arm that achieve bony union
time to union
Time frame: 6 to 24 weeks
the time that patient take to achieve bony union
wrist flexion and extension
Time frame: preoperative, at 6 months and at 24 months
flexion and extension range of motion
wrist radial and ulnar deviation
Time frame: preoperative, at 6 months and at 24 months
radial and ulnar deviation range of motion
grip strength
Time frame: preoperative , at 6 months and at 24 months
the power of hand grip measured by dynamometer
The disability of arm, shoulder and hand score (DASH score)
Time frame: preoperative , at 6 months and at 24 months
a questionnaire to assess upper limb function from 0 to 100 where the lower the score means better outcome
The Mayo modified wrist score
Time frame: preoperative, at 6 months and at 24 months
A functional score that depends on the patients function and examination from 0 to 100 and the higher the score the higher the outcome
3 secondary outcomes
complications
Time frame: 2 years post operative
Degree of scaphoid hump back deformity correction
Time frame: post operative after bony union up to 1 year
Operative time
Time frame: intraoperative
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 6 Jan 2026.
- Background: PubMed 26051763Jegal M, Kim JS, Kim JP. Arthroscopic Management of Scaphoid Nonunions. Hand Surg. 2015;20(2):215-21. doi: 10.1142/S0218810415400031.
- Results publication: PubMed 15513497Munk B, Larsen CF. Bone grafting the scaphoid nonunion: a systematic review of 147 publications including 5,246 cases of scaphoid nonunion. Acta Orthop Scand. 2004 Oct;75(5):618-29. doi: 10.1080/00016470410001529.
- Individual participant dataSharing planned: No
Related trials for Scaphoid Fracture Non Union
Recruiting
Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
Scaphoid Fracture, Scaphoid Nonunion
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.
Mohammed El-Mahy, prof. study chair
Ain Shams 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 Arthroscopic grafting and k wires fixation and open scaphoid grafting with K wires fixation in people with Scaphoid Fracture Non Union, run by Ain Shams 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 4 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 6 Jan 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 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?
union rate (time frame: 6 months). The study lists 7 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 NCT07320404, which also lists 2 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 6 Jan 2026.