Scaphoid FractureNCT05358015
Vascularized Bone Grafts for Treatment of Scaphoid Nonunion
A study testing vascularized bone graft for scaphois nonunion in people with Scaphoid Fracture, run by Assiut University.
Trial summary
To assess the effect of vascularized bone grafting on the functional, clinical and radiological outcomes of the scaphoid nonunion Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Scaphoid Fracture
- What is being tested?
- vascularized bone graft for scaphois nonunion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 1 Sep 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All Patients will be included if they met the following criteria:
- Age: all patient more than 18 years up to 55 years
- Fracture: nonunion and a vascular necrosis proved by MRI (Herbert stage I or II) , humpback deformity, Proximal pole fracture, cystic degeneration, failed previous surgery (K wire, Herbert, plate distal radius)
- Pain: persistent disabling pain and tenderness at wrist joint due to scaphoid nonunion.
- patient: both sex will included, both handiness, good bone quality.
Who cannot join
- Commuted Other carpus fractures
- Nonunion less than 3 months
- Radio-carpal Arthritis or instability
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vascularised Bone Grafts for Treatment of Scaphoid Nonunion: a Case Series Study
To assess the effect of vascularized bone grafting on the functional, clinical and radiological outcomes of the scaphoid nonunion
Read the detailed description
The scaphoid is the most commonly fractured carpal bone accounting for 60% of fractures. A number of case series have identified a 10%-15% nonunion rate. Scaphoid nonunion refers to a spectrum of failed healing, each of which requires a tailored approach.
Subsequent to non-union, degenerative changes with the formation of cysts, bony resorption with loss of bone stock and the development of apex dorsal angulation or the humpback deformity may occur leading to scaphoid non-union advanced collapse (SNAC) of the wrist and the formation of a proximal pole which extends with the lunate.
This has serious functional implications for the patient in terms of wrist range of movement, grip strength and general activities of daily living . The management of nonunion has remained controversial since the last century.
Bone grafting has been performed since the late 1920s with positive results. The importance of vascularity was enforced by finding that in the presence of avascular necrosis ( AVN ), conventional non vascularized bone grafts ( NVBGs) could only achieve a 47% union rate . However, in the absence of AVN, these NVBGs could achieve union rates of 94% .
There was growing consensus that new techniques were required to address the shortfall, and accordingly, vascularized bone grafting (VBG) techniques stemmed from this. It was widely believed that providing adequate blood flow would help treat cases of non-union . Several studies demonstrate that VBGs accelerated bone healing by preserving osteocytes and preventing the slower creeping substitution and were able to increase blood flow and superior mechanical properties in VBGs as opposed to NVBGs . VBGs could be further classified into pedicled or free VBGs. Pedicled VBGs involve isolating a segment of bone local to the defect and maintaining the blood supply to this segment of donor bone which is then fixed into the recipient site. This requires a good stock of donor bone in close proximity to the defect. Free VBGs involve detaching a segment of bone with its vascular bundle from a donor site and anastomosing this to recipient vessels with the fixation of the donor bone to recipient bone.This study hypothesis that VBGs should be used in all cases of humpback deformity , proximal pole fracture , AVN and cystic degeneration from the start.
- Conditions
- Scaphoid Fracture
- Being tested
- vascularized bone graft for scaphois nonunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascularized bone graft for scaphois nonunionProcedure or surgery
vascularized bone graft for scaphois nonunion
| Study group | Role | What they receive |
|---|---|---|
| scaphoid nonunion | Experimental | pedicled and free ABG for treatment of scaphoid nonunion Receives: Procedure: vascularized bone graft for scaphois nonunion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29
The final end results will be assessed according to DASH score , a DASH score ranging from 0 to 29 was thought by most respondents to be the point where patients/clients were 'no longer considering their upper-limb disorder a problem .
Measured: 2 years
Mayo wrist score of 60 - 100 will be satisfactory
The final end results will be assessed according to modified Mayo wrist score of 60 - 100 will be satisfactory .
Secondary (subsidiary):
Measured: 2 years
Secondary outcomes (5)
Carpal Alignment Before and After VBG
the articular surfaces of the proximal and distal carpal rows should form three smooth arcs , the spacing between all carpal bones should be 1-2 mm in antroposterior view and the distal radius, lunate and capitate should be in a straight line in lateral view
Measured: 2 years
Scaphoid Height-to-length ratio
The mean normal H/L ratio in the sagittal plane was 0.61 (range, 0.54-0.69) and in the coronal plane 0.42 (range, 0.36-0.48).
Measured: 2 years
Scapholunate angle
Scapholunate angle is the angle between longitudinal axes of lunate and scaphoid (tangential line from the dorsum of scaphoid) in the lateral radiograph the scapholunate angle should be between 30o and 60o in the neutral position
Measured: 2 years
Radio-lunate angle
Radiolunate angle is the angle between the longitudinal axes of radius and lunate in lateral view
Measured: 2 years
Lateral interscaphoid angle
Normal lateral intrascaphoid angle averages 30 degrees
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start15 May 2022 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Scaphoid FractureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mostafa abdelhady Ismail, Assiut University
- Investigators
- Mohamed Kotb, M.D, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358015
- Sponsor's protocol ID
- VBGs for scaphoid nonunion
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dias JJ, Brenkel IJ, Finlay DB. Patterns of union in fractures of the waist of the scaphoid. J Bone Joint Surg Br. 1989 Mar;71(2):307-10. doi: 10.1302/0301-620X.71B2.2925752.
PubMed 2925752Szabo RM, Manske D. Displaced fractures of the scaphoid. Clin Orthop Relat Res. 1988 May;(230):30-8.
PubMed 3284681El-Karef EA. Corrective osteotomy for symptomatic scaphoid malunion. Injury. 2005 Dec;36(12):1440-8. doi: 10.1016/j.injury.2005.09.003. Epub 2005 Oct 27.
PubMed 16256995Lynch NM, Linscheid RL. Corrective osteotomy for scaphoid malunion: technique and long-term follow-up evaluation. J Hand Surg Am. 1997 Jan;22(1):35-43. doi: 10.1016/S0363-5023(05)80177-7.
PubMed 9018610
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularised Bone Grafts for Treatment of Scaphoid Nonunion: a Case Series Study
- ClinicalTrials.gov ID
- NCT05358015
- Acronym / sponsor ID
- VBGs for scaphoid nonunion
- Conditions
- Scaphoid Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 May 2022 (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.
To assess the effect of vascularized bone grafting on the functional, clinical and radiological outcomes of the scaphoid nonunion
Detailed description
The scaphoid is the most commonly fractured carpal bone accounting for 60% of fractures. A number of case series have identified a 10%-15% nonunion rate. Scaphoid nonunion refers to a spectrum of failed healing, each of which requires a tailored approach.
Subsequent to non-union, degenerative changes with the formation of cysts, bony resorption with loss of bone stock and the development of apex dorsal angulation or the humpback deformity may occur leading to scaphoid non-union advanced collapse (SNAC) of the wrist and the formation of a proximal pole which extends with the lunate.
This has serious functional implications for the patient in terms of wrist range of movement, grip strength and general activities of daily living . The management of nonunion has remained controversial since the last century.
Bone grafting has been performed since the late 1920s with positive results. The importance of vascularity was enforced by finding that in the presence of avascular necrosis ( AVN ), conventional non vascularized bone grafts ( NVBGs) could only achieve a 47% union rate . However, in the absence of AVN, these NVBGs could achieve union rates of 94% .
There was growing consensus that new techniques were required to address the shortfall, and accordingly, vascularized bone grafting (VBG) techniques stemmed from this. It was widely believed that providing adequate blood flow would help treat cases of non-union . Several studies demonstrate that VBGs accelerated bone healing by preserving osteocytes and preventing the slower creeping substitution and were able to increase blood flow and superior mechanical properties in VBGs as opposed to NVBGs . VBGs could be further classified into pedicled or free VBGs. Pedicled VBGs involve isolating a segment of bone local to the defect and maintaining the blood supply to this segment of donor bone which is then fixed into the recipient site. This requires a good stock of donor bone in close proximity to the defect. Free VBGs involve detaching a segment of bone with its vascular bundle from a donor site and anastomosing this to recipient vessels with the fixation of the donor bone to recipient bone.This study hypothesis that VBGs should be used in all cases of humpback deformity , proximal pole fracture , AVN and cystic degeneration from the start.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| scaphoid nonunion | Experimental | Procedure: vascularized bone graft for scaphois nonunionpedicled and free ABG for treatment of scaphoid nonunion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: all patient more than 18 years up to 55 years
- Fracture: nonunion and a vascular necrosis proved by MRI (Herbert stage I or II) , humpback deformity, Proximal pole fracture, cystic degeneration, failed previous surgery (K wire, Herbert, plate distal radius)
- Pain: persistent disabling pain and tenderness at wrist joint due to scaphoid nonunion.
- patient: both sex will included, both handiness, good bone quality.
Key exclusion criteria (3 listed)
- Commuted Other carpus fractures
- Nonunion less than 3 months
- Radio-carpal Arthritis or 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 |
|---|---|---|
| vascularized bone graft for scaphois nonunionvascularized bone graft for scaphois nonunion | Procedure or surgery | scaphoid nonunion |
Primary outcome
Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29
Time frame: 2 years
The final end results will be assessed according to DASH score , a DASH score ranging from 0 to 29 was thought by most respondents to be the point where patients/clients were 'no longer considering their upper-limb disorder a problem .
Mayo wrist score of 60 - 100 will be satisfactory
Time frame: 2 years
The final end results will be assessed according to modified Mayo wrist score of 60 - 100 will be satisfactory . Secondary (subsidiary):
5 secondary outcomes
Carpal Alignment Before and After VBG
Time frame: 2 years
Scaphoid Height-to-length ratio
Time frame: 2 years
Scapholunate angle
Time frame: 2 years
Radio-lunate angle
Time frame: 2 years
Lateral interscaphoid angle
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Background: PubMed 2925752Dias JJ, Brenkel IJ, Finlay DB. Patterns of union in fractures of the waist of the scaphoid. J Bone Joint Surg Br. 1989 Mar;71(2):307-10. doi: 10.1302/0301-620X.71B2.2925752.
- Background: PubMed 3284681Szabo RM, Manske D. Displaced fractures of the scaphoid. Clin Orthop Relat Res. 1988 May;(230):30-8.
- Background: PubMed 16256995El-Karef EA. Corrective osteotomy for symptomatic scaphoid malunion. Injury. 2005 Dec;36(12):1440-8. doi: 10.1016/j.injury.2005.09.003. Epub 2005 Oct 27.
- Background: PubMed 9018610Lynch NM, Linscheid RL. Corrective osteotomy for scaphoid malunion: technique and long-term follow-up evaluation. J Hand Surg Am. 1997 Jan;22(1):35-43. doi: 10.1016/S0363-5023(05)80177-7.
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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.
Mohamed Kotb, M.D study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing vascularized bone graft for scaphois nonunion in people with Scaphoid Fracture, run by Assiut University.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ismail, master (00201025445484, drortho87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29 (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT05358015, which also lists 4 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 3 May 2022.