Scaphoid FractureNCT05362240
Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in SNAC Wrist
A study testing Four corner fusion and three corner fusion without triquetrum excision in people with Scaphoid Fracture, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigator compare two types of limited wrist arthrodesis used for management of cases with scaphoid non union advanced collapse (SNAC) as regard the outcome to provide the most suitable technique Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Scaphoid Fracture
- What is being tested?
- Four corner fusion and three corner fusion without triquetrum excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2018to 2 Dec 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- SNAC wrist G II , III
Who cannot join
- cases with radiolunate arthritis
- Scapholunate advanced collapse
- Grade 1 Scaphoid non union advanced collapse
- Kienbock disease
- Skeletally immature patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University , Faculty of medicine
Al ‘Abbāsīyah, Cairo Governorate, 11655
About this study
Official title: Functional Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in Scaphoid Non Union Advanced Collapse (SNAC) Wrist Grade II and III : a Prospective Randomized Controlled Trial
The investigator compare two types of limited wrist arthrodesis used for management of cases with scaphoid non union advanced collapse (SNAC) as regard the outcome to provide the most suitable technique
Read the detailed description
There is a controversy regarding the suitable limited wrist arthrodesis technique for SNAC wrist grade II and III . For several decades , scaphoid excision and four corner fusion (between lunate , capitate , hamate and triquetrum) was the gold standard with good functional outcomes . Later on , a more limited fusion technique was described , three corner fusion ( between lunate , capitate and hamate) with scaphoid and triquetrum excision to improve ulnar deviation range . On the other hand , biomechanical studies mentioned that the triquetrum had a certain proprioceptive function that could be affected when it was included in the fusion process .Furthermore , if the triquetrum was excised the radiolunate contact pressure would increase with higher risk of development of arthritis. The aim of the study to compare the conventional four corner fusion with three corner fusion with triquetrum excision
- Conditions
- Scaphoid Fracture
- Being tested
- Four corner fusion, three corner fusion without triquetrum excision
- Keywords
- SNAC wrist, Four-corner fusion, Three corner fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four corner fusionProcedure or surgery
Also called four corner arthrodesis
First , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denuded the articulating surfaces between lunate , capitate , hamate and triquetrum . Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones
three corner fusion without triquetrum excisionProcedure or surgery
First , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denude the articulating surfaces between lunate , capitate , hamate and don not include triquetrum. Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones.
| Study group | Role | What they receive |
|---|---|---|
| Four corner fusion | Experimental | Scaphoid excision and fusion between lunate , capitate , hamate and triquetrum using k.wires Receives: Procedure: Four corner fusion |
| Three corner fusion without triquetrum excision | Experimental | Scaphoid excision with fusion between lunate , capitate and hamate with preservation of triquetrum Receives: Procedure: three corner fusion without triquetrum excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
measuring range of motion and sagittal and coronal plane using goniometer
Measured: preoperative
Range of motion
measuring range of motion and sagittal and coronal plane using goniometer
Measured: one year postoperative
Power grip
Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side
Measured: preoperative
Power grip
Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side
Measured: one year postoperative
Secondary outcomes (5)
operative time
measuring the operative time
Measured: Intraoperative
Visual analogue scale
Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain
Measured: preoperative
Visual analogue scale
Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain .
Measured: one year postoperative
Patient satisfaction
Modified Mayo wrist score which involves both patient and physician participation. The scale runs from 0 to 100, with 0 representing a worse wrist condition and 100 suggesting a better wrist condition. It assess discomfort, active flexion/extension arc (in contrast to the contralateral side), grip strength (in comparison to the contralateral side), and the capacity to return to regular job or activities.
Measured: preoperative
Patient satisfaction
Modified Mayo wrist score which involves both patient and physician participation. The scale runs from 0 to 100, with 0 representing a worse wrist condition and 100 suggesting a better wrist condition. It assess discomfort, active flexion/extension arc (in contrast to the contralateral side), grip strength (in comparison to the contralateral side), and the capacity to return to regular job or activities.
Measured: one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start20 Sep 2018
- Primary completion30 Oct 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 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
- Two groups with the first intervention four corner fusion , and the second with three corner fusion without triquetrum excision
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed M Elmahy, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362240
- Sponsor's protocol ID
- FMASU M D 296/2019
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bain GI, Sood A, Ashwood N, Turner PC, Fogg QA. Effect of scaphoid and triquetrum excision after limited stabilisation on cadaver wrist movement. J Hand Surg Eur Vol. 2009 Oct;34(5):614-7. doi: 10.1177/1753193408094923. Epub 2009 Jul 10.
PubMed 19592604Scobercea RG, Budoff JE, Hipp JA. Biomechanical effect of triquetral and scaphoid excision on simulated midcarpal arthrodesis in cadavers. J Hand Surg Am. 2009 Mar;34(3):381-6. doi: 10.1016/j.jhsa.2008.11.027.
PubMed 19258133Delattre O, Goulon G, Vogels J, Wavreille G, Lasnier A. Three-Corner Arthrodesis With Scaphoid and Triquetrum Excision for Wrist Arthritis. J Hand Surg Am. 2015 Nov;40(11):2176-82. doi: 10.1016/j.jhsa.2015.07.032. Epub 2015 Sep 26.
PubMed 26409577
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in Scaphoid Non Union Advanced Collapse (SNAC) Wrist Grade II and III : a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05362240
- Acronym / sponsor ID
- FMASU M D 296/2019
- Conditions
- Scaphoid Fracture
- Keywords
- SNAC wrist, Four-corner fusion, Three corner fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 5 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.
The investigator compare two types of limited wrist arthrodesis used for management of cases with scaphoid non union advanced collapse (SNAC) as regard the outcome to provide the most suitable technique
Detailed description
There is a controversy regarding the suitable limited wrist arthrodesis technique for SNAC wrist grade II and III . For several decades , scaphoid excision and four corner fusion (between lunate , capitate , hamate and triquetrum) was the gold standard with good functional outcomes . Later on , a more limited fusion technique was described , three corner fusion ( between lunate , capitate and hamate) with scaphoid and triquetrum excision to improve ulnar deviation range . On the other hand , biomechanical studies mentioned that the triquetrum had a certain proprioceptive function that could be affected when it was included in the fusion process .Furthermore , if the triquetrum was excised the radiolunate contact pressure would increase with higher risk of development of arthritis. The aim of the study to compare the conventional four corner fusion with three corner fusion with triquetrum excision
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups with the first intervention four corner fusion , and the second with three corner fusion without triquetrum excision
| Arm | Type | Receives |
|---|---|---|
| Four corner fusion | Experimental | Procedure: Four corner fusionScaphoid excision and fusion between lunate , capitate , hamate and triquetrum using k.wires |
| Three corner fusion without triquetrum excision | Experimental | Procedure: three corner fusion without triquetrum excisionScaphoid excision with fusion between lunate , capitate and hamate with preservation of triquetrum |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- SNAC wrist G II , III
Key exclusion criteria (5 listed)
- cases with radiolunate arthritis
- Scapholunate advanced collapse
- Grade 1 Scaphoid non union advanced collapse
- Kienbock disease
- Skeletally immature patients
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 |
|---|---|---|
| Four corner fusionAlso: four corner arthrodesisFirst , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denuded the articulating surfaces between lunate , capitate , hamate and triquetrum . Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones | Procedure or surgery | Four corner fusion |
| three corner fusion without triquetrum excisionFirst , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denude the articulating surfaces between lunate , capitate , hamate and don not include triquetrum. Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones. | Procedure or surgery | Three corner fusion without triquetrum excision |
Primary outcome
Range of motion
Time frame: preoperative
measuring range of motion and sagittal and coronal plane using goniometer
Range of motion
Time frame: one year postoperative
measuring range of motion and sagittal and coronal plane using goniometer
Power grip
Time frame: preoperative
Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side
Power grip
Time frame: one year postoperative
Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side
5 secondary outcomes
operative time
Time frame: Intraoperative
Visual analogue scale
Time frame: preoperative
Visual analogue scale
Time frame: one year postoperative
Patient satisfaction
Time frame: preoperative
Patient satisfaction
Time frame: one year postoperative
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 5 May 2022.
- Background: PubMed 19592604Bain GI, Sood A, Ashwood N, Turner PC, Fogg QA. Effect of scaphoid and triquetrum excision after limited stabilisation on cadaver wrist movement. J Hand Surg Eur Vol. 2009 Oct;34(5):614-7. doi: 10.1177/1753193408094923. Epub 2009 Jul 10.
- Background: PubMed 19258133Scobercea RG, Budoff JE, Hipp JA. Biomechanical effect of triquetral and scaphoid excision on simulated midcarpal arthrodesis in cadavers. J Hand Surg Am. 2009 Mar;34(3):381-6. doi: 10.1016/j.jhsa.2008.11.027.
- Background: PubMed 26409577Delattre O, Goulon G, Vogels J, Wavreille G, Lasnier A. Three-Corner Arthrodesis With Scaphoid and Triquetrum Excision for Wrist Arthritis. J Hand Surg Am. 2015 Nov;40(11):2176-82. doi: 10.1016/j.jhsa.2015.07.032. Epub 2015 Sep 26.
- Individual participant dataSharing planned: No
Related trials for Scaphoid Fracture
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
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.
Mohamed M Elmahy, Professor 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 Four corner fusion and three corner fusion without triquetrum excision in people with Scaphoid Fracture, 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 1 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 5 May 2022. 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?
Range of motion (time frame: preoperative). 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 NCT05362240, which also lists 3 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 5 May 2022.