Closed Fracture Scaphoid, Proximal PoleNCT05525988
Proximal Pole Scaphoid Reconstruction Using Proximal Hamate
A study testing Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction in people with Closed Fracture Scaphoid, Proximal Pole and A Proximal Pole of Scaphoid That is Deemed Unsalvageable, run by Ain Shams University at 1 site in Egypt.
Trial summary
Recently, A novel surgical technique was illustrated by Elhassan BT et al. in 2016 utilizing the Hemi-hamate autograft for the reconstruction of scaphoid bone proximal pole non-union with avascular necrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closed Fracture Scaphoid, Proximal Pole, A Proximal Pole of Scaphoid That is Deemed Unsalvageable
- What is being tested?
- Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multifragmentary fracture of the proximal pole of scaphoid where fragments cannot be fixated.
- Participants with small and poor-quality proximal pole scaphoid bone fracture after the failure of a previous surgical fixation or bone grafting.
Who cannot join
- Proximal hamate arthrosis.
- Preexisting midcarpal instability.
- Arthritis at the radioscaphoid joint.
- Large hamate bone (Hamate radial-ulnar breadth greater than 1 cm in a participant with scaphoid bone radial-ulnar breadth less than 1 cm and palmar-dorsal breadth of less than 1.6 cm).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proximal Pole Scaphoid Reconstruction Using Proximal Hamate: Case-Series on A Novel Technique
Recently, A novel surgical technique was illustrated by Elhassan BT et al. in 2016 utilizing the Hemi-hamate autograft for the reconstruction of scaphoid bone proximal pole non-union with avascular necrosis.
The technique showed promising results but is still limited to case reports and anatomical studies
In this study, we aim to:
- Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique.
- Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function.
- Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.
Read the detailed description
Almost 70 percent of all carpal bone fractures occur in the scaphoid bone, with an overall incidence of 12 per 100,000 of the general population. About 20 percent of scaphoid bone fractures are in the proximal third of the scaphoid, where the rates of ischemia were reported to be as high as 100 percent.
The risk of avascular necrosis (AVN) and/or non-union that in due course end in arthrosis with the fractures involving the proximal pole of the scaphoid is high and represents a challenging surgical problem, and even more challenging when the proximal pole is fragmented.
Several techniques were described for the surgical management of non-union of the proximal pole of scaphoid, including non-vascularised and vascularized bone grafts, each has characteristic pros and cons. Drawbacks with all of these techniques included donor-site morbidity and/or the requirement of microvascular skill in the case of a vascularized bone graft.
The Hemi-Hamate graft is the closest anatomically and histologically to the scaphoid compared to the rib costochondral and the medial femoral condyle grafts. The proximal part of the hamate has an analogous sizing and morphology to the proximal pole of the scaphoid bone. Both have a similar depth (palmar-dorsal breadth), width (radial-ulnar breadth), and sagittal radius of curvature.
Osteotomized proximal hamate with a maximum graft length at a level proximal to the hamulus distally did not adversely affect the lunate-capitate or the scaphoid-lunate kinematics during the wrist joint flexion-extension and the radial-ulnar deviation.
Since the technique was first described in 2016 only a single case-report study existed in the literature regarding the H-H autograft. Elhassan BT et al. reported that at 3.5-years follow-up the patient was free-pain, the wrist range of motion improved significantly and the Mayo wrist score was 90 which is coherent to an excellent outcome and, no symptoms of midcarpal instability were detected during 3.5-years follow-up.
The first case series published in the literature regarding the use of the Hemi-Hamate autograft was published by Saruhan S et al. in 2021; the study had a limited number of participants (4 cases) and, it was a retrospective study. In these four cases, the union was achieved, the pain was decreased, and there were no signs of donor-site morbidity at the final follow-up.
All probable complications have not been elucidated yet given the infancy stage of the technique description. Therefore, we decided to conduct a prospective case series study to report the outcomes of this newly developed promising technique and outline any possible drawbacks.
The investigators believe that this study will add significantly to the orthopedic literature given the infancy stage of this technique description.
Objectives:
- Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique.
- Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function.
- Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.
- Conditions
- Closed Fracture Scaphoid, Proximal Pole, A Proximal Pole of Scaphoid That is Deemed Unsalvageable
- Being tested
- Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction
- Keywords
- Proximal Pole Scaphoid Reconstruction, Hemi-Hamate Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemi-Hamate Transfer for Proximal Pole Scaphoid ReconstructionProcedure or surgery
Surgical Technique:
The participants will be positioned in the supine decubitus on the surgical table with the operated upper limb put on a C-arm (Mobile fluoroscopy device) compatible surgical arm-board. After anesthesia, a pneumatic tourniquet will be placed with a cuff pressure raised to 250 mmHg, then the limb is draped in the regular sterile fashion. Through a dorsal approach to the wrist joint, the proximal pole of scaphoid bone will be assessed before resectioning for confirmation that it cannot be preserved. The hamate bone will be exposed through capsulotomy and the measurements of the resected scaphoid will be transferred. The harvested H-H autograft will be placed and fixed to the distal scaphoid segment. Wound closure is then performed in layers in the usual fashion, and the wound will be covered by a sterile gauze, then a short-arm thumb spica splint will be put on.
| Study group | Role | What they receive |
|---|---|---|
| Hemi-Hamate Graft for Proximal Pole Scaphoid Reconstruction | Experimental | [All participants enrolled in this study for proximal pole scaphoid reconstruction using the Hemi-Hamate autograft] Receives: Procedure: Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union Rate
Reaching 50 percent graft union at the fracture site by Computed Tomography (CT) utilizing 1 mm thin cuts along the scaphoid long axis. [Done at the 6-week post-operative clinic visit to assess for the bone union and will be performed in monthly intervals till the bony union.]
Measured: 6 months postoperatively
Secondary outcomes (2)
Time to Union
The time needed for the graft to reach 50 percent union at the fracture site by Computed Tomography (CT) utilizing 1 mm thin cuts along the scaphoid long axis. [Done at the 6-week post-operative clinic visit to assess for the bone union and will be performed in monthly intervals till the bony union.]
Measured: A 6 months postoperatively
Complications
Graft failure, malposition, malunion, delayed union, persistent non-union, carpal instability, and arthritis, as well as excessive scarring and complex regional pain syndrome, are all theoretically possible complications of this procedure.
Measured: Intraoperatively to 1-year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start15 Mar 2022
- Primary completion30 Sep 2022
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Closed Fracture Scaphoid, Proximal PoleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Mohamed Ashraf Abdelfatah Rabie, Orthopedic Surgery Specialist,, Principal investigator, Ain Shams UniversityAyman Ibrahim Fathy Aly Hewaidy, Professor of Orthopedic Surgery,, Study chair, Faculty of Medicine, Ain Shams UniversityAhmed Naeem Atiyya Aly, Professor of Orthopedic Surgery,, Study director, Faculty of Medicine, Ain Shams UniversityAmr Mostafa Mohamed Aly, Assistant Professor of Orthopedic Surgery,, Study director, Faculty of Medicine, Ain Shams UniversityRamy Ahmed Aly Soliman, Lecturer of Orthopedic Surgery,, Study director, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525988
- Sponsor's protocol ID
- FMASU MD 38/2022_FWA 00017585
- Status last verified
- Oct 2022
- First submitted
- 31 Aug 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chambers SB, Suh N. Proximal Hamate Autograft for Scaphoid Fractures: Surgical Anatomy and Technique. In: Bhatia DN, Bain GI, Poehling GG, Graves BR, eds. Arthroscopy and Endoscopy of the Elbow, Wrist and Hand. Springer, Cham; 2022: 899-905. https://doi.org/10.1007/978-3-030-79423-1_98
Elhassan B, Noureldin M, Kakar S. Proximal Scaphoid Pole Reconstruction Utilizing Ipsilateral Proximal Hamate Autograft. Hand (N Y). 2016 Dec;11(4):495-499. doi: 10.1177/1558944716628497. Epub 2016 Mar 3.
PubMed 28149221Chan AHW, Elhassan BT, Suh N. The Use of the Proximal Hamate as an Autograft for Proximal Pole Scaphoid Fractures: Clinical Outcomes and Biomechanical Implications. Hand Clin. 2019 Aug;35(3):287-294. doi: 10.1016/j.hcl.2019.03.007. Epub 2019 May 11.
PubMed 31178087Saruhan S, Savran A, Yildiz M, Sener M. Reconstruction of proximal pole scaphoid non-union with avascular necrosis using proximal hamate: A four-case series. Hand Surg Rehabil. 2021 Dec;40(6):744-748. doi: 10.1016/j.hansur.2021.07.003. Epub 2021 Jul 16.
PubMed 34274497Wang DY, Li X, Shen ZC, Gu PL, Pei YR, Zeng G, Leng HJ, Zhang WG. [Three-dimensional architecture of intraosseous vascular anatomy of the hamate: a micro-computed tomography study]. Beijing Da Xue Xue Bao Yi Xue Ban. 2018 Apr 18;50(2):245-248. Chinese.
PubMed 29643522Wu K, Padmore C, Lalone E, Suh N. An Anthropometric Assessment of the Proximal Hamate Autograft for Scaphoid Proximal Pole Reconstruction. J Hand Surg Am. 2019 Jan;44(1):60.e1-60.e8. doi: 10.1016/j.jhsa.2018.04.021. Epub 2018 Jun 20.
PubMed 29934078Kakar S, Greene RM, Hewett T, Thoreson AR, Hooke AW, Elhassan BT. The Effect of Proximal Hamate Osteotomy on Carpal Kinematics for Reconstruction of Proximal Pole Scaphoid Nonunion With Avascular Necrosis. Hand (N Y). 2020 May;15(3):371-377. doi: 10.1177/1558944718793175. Epub 2018 Aug 20.
PubMed 30124083Sollaccio DR, Navo P, Ghiassi A, Orr CM, Patel BA, Lewton KL. Evaluation of Articular Surface Similarity of Hemi-Hamate Grafts and Proximal Middle Phalanx Morphology: A 3D Geometric Morphometric Approach. J Hand Surg Am. 2019 Feb;44(2):121-128. doi: 10.1016/j.jhsa.2018.06.008. Epub 2018 Jul 14.
PubMed 30017649Kakar S, Greene RM, Elhassan BT, Holmes DR 3rd. Topographical Analysis of the Hamate for Proximal Pole Scaphoid Nonunion Reconstruction. J Hand Surg Am. 2020 Jan;45(1):69.e1-69.e7. doi: 10.1016/j.jhsa.2019.05.013. Epub 2019 Jul 9.
PubMed 31300229Thayer MK, Bluth B, Huang JI. A Morphometric Analysis of Hamate Autograft for Proximal Scaphoid Reconstruction. J Wrist Surg. 2021 Jun;10(3):268-271. doi: 10.1055/s-0041-1726404. Epub 2021 Apr 14.
PubMed 34109073Robinson PG, Duckworth AD, Campbell DA. Acute Fractures in Sport: Wrist. In: Robertson GAJ, Maffulli N, eds. Fractures in Sport. Springer, Cham; 2021:155-174. https://doi.org/10.1007/978-3-030-72036-0_11
Segalman KA, Graham TJ. Scaphoid Proximal Pole fractures and Nonunions. J. Am. Soc. Surg. Hand. 2004;4(4): 233-249. doi:10.1016/j.jassh.2004.09.008
Gillis JA, Elhassan BT, Kakar S. Hamate to Scaphoid Transfer for Nonreconstructable Proximal Pole Scaphoid Fractures. In: Geissler WB, ed. Wrist and Elbow Arthroscopy with Selected Open Procedures. Springer, Cham; 2022: 555-559. https://doi.org/10.1007/978-3-030-78881-0_44
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Pole Scaphoid Reconstruction Using Proximal Hamate: Case-Series on A Novel Technique
- ClinicalTrials.gov ID
- NCT05525988
- Acronym / sponsor ID
- FMASU MD 38/2022_FWA 00017585
- Conditions
- Closed Fracture Scaphoid, Proximal Pole, A Proximal Pole of Scaphoid That is Deemed Unsalvageable
- Keywords
- Proximal Pole Scaphoid Reconstruction, Hemi-Hamate Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 2 Sep 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.
Recently, A novel surgical technique was illustrated by Elhassan BT et al. in 2016 utilizing the Hemi-hamate autograft for the reconstruction of scaphoid bone proximal pole non-union with avascular necrosis.
The technique showed promising results but is still limited to case reports and anatomical studies
In this study, we aim to:
- Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique.
- Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function.
- Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.
Detailed description
Almost 70 percent of all carpal bone fractures occur in the scaphoid bone, with an overall incidence of 12 per 100,000 of the general population. About 20 percent of scaphoid bone fractures are in the proximal third of the scaphoid, where the rates of ischemia were reported to be as high as 100 percent.
The risk of avascular necrosis (AVN) and/or non-union that in due course end in arthrosis with the fractures involving the proximal pole of the scaphoid is high and represents a challenging surgical problem, and even more challenging when the proximal pole is fragmented.
Several techniques were described for the surgical management of non-union of the proximal pole of scaphoid, including non-vascularised and vascularized bone grafts, each has characteristic pros and cons. Drawbacks with all of these techniques included donor-site morbidity and/or the requirement of microvascular skill in the case of a vascularized bone graft.
The Hemi-Hamate graft is the closest anatomically and histologically to the scaphoid compared to the rib costochondral and the medial femoral condyle grafts. The proximal part of the hamate has an analogous sizing and morphology to the proximal pole of the scaphoid bone. Both have a similar depth (palmar-dorsal breadth), width (radial-ulnar breadth), and sagittal radius of curvature.
Osteotomized proximal hamate with a maximum graft length at a level proximal to the hamulus distally did not adversely affect the lunate-capitate or the scaphoid-lunate kinematics during the wrist joint flexion-extension and the radial-ulnar deviation.
Since the technique was first described in 2016 only a single case-report study existed in the literature regarding the H-H autograft. Elhassan BT et al. reported that at 3.5-years follow-up the patient was free-pain, the wrist range of motion improved significantly and the Mayo wrist score was 90 which is coherent to an excellent outcome and, no symptoms of midcarpal instability were detected during 3.5-years follow-up.
The first case series published in the literature regarding the use of the Hemi-Hamate autograft was published by Saruhan S et al. in 2021; the study had a limited number of participants (4 cases) and, it was a retrospective study. In these four cases, the union was achieved, the pain was decreased, and there were no signs of donor-site morbidity at the final follow-up.
All probable complications have not been elucidated yet given the infancy stage of the technique description. Therefore, we decided to conduct a prospective case series study to report the outcomes of this newly developed promising technique and outline any possible drawbacks.
The investigators believe that this study will add significantly to the orthopedic literature given the infancy stage of this technique description.
Objectives:
- Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique.
- Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function.
- Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemi-Hamate Graft for Proximal Pole Scaphoid Reconstruction | Experimental | Procedure: Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction[All participants enrolled in this study for proximal pole scaphoid reconstruction using the Hemi-Hamate autograft] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Multifragmentary fracture of the proximal pole of scaphoid where fragments cannot be fixated.
- Participants with small and poor-quality proximal pole scaphoid bone fracture after the failure of a previous surgical fixation or bone grafting.
Key exclusion criteria (4 listed)
- Proximal hamate arthrosis.
- Preexisting midcarpal instability.
- Arthritis at the radioscaphoid joint.
- Large hamate bone (Hamate radial-ulnar breadth greater than 1 cm in a participant with scaphoid bone radial-ulnar breadth less than 1 cm and palmar-dorsal breadth of less than 1.6 cm).
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 |
|---|---|---|
| Hemi-Hamate Transfer for Proximal Pole Scaphoid ReconstructionSurgical Technique: The participants will be positioned in the supine decubitus on the surgical table with the operated upper limb put on a C-arm (Mobile fluoroscopy device) compatible surgical arm-board. After anesthesia, a pneumatic tourniquet will be placed with a cuff pressure raised to 250 mmHg, then the limb is draped in the regular sterile fashion. Through a dorsal approach to the wrist joint, the proximal pole of scaphoid bone will be assessed before resectioning for confirmation that it cannot be preserved. The hamate bone will be exposed through capsulotomy and the measurements of the resected scaphoid will be transferred. The harvested H-H autograft will be placed and fixed to the distal scaphoid segment. Wound closure is then performed in layers in the usual fashion, and the wound will be covered by a sterile gauze, then a short-arm thumb spica splint will be put on. | Procedure or surgery | Hemi-Hamate Graft for Proximal Pole Scaphoid Reconstruction |
Primary outcome
Union Rate
Time frame: 6 months postoperatively
Reaching 50 percent graft union at the fracture site by Computed Tomography (CT) utilizing 1 mm thin cuts along the scaphoid long axis. [Done at the 6-week post-operative clinic visit to assess for the bone union and will be performed in monthly intervals till the bony union.]
2 secondary outcomes
Time to Union
Time frame: A 6 months postoperatively
Complications
Time frame: Intraoperatively to 1-year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- BackgroundChambers SB, Suh N. Proximal Hamate Autograft for Scaphoid Fractures: Surgical Anatomy and Technique. In: Bhatia DN, Bain GI, Poehling GG, Graves BR, eds. Arthroscopy and Endoscopy of the Elbow, Wrist and Hand. Springer, Cham; 2022: 899-905. https://doi.org/10.1007/978-3-030-79423-1_98
- Background: PubMed 28149221Elhassan B, Noureldin M, Kakar S. Proximal Scaphoid Pole Reconstruction Utilizing Ipsilateral Proximal Hamate Autograft. Hand (N Y). 2016 Dec;11(4):495-499. doi: 10.1177/1558944716628497. Epub 2016 Mar 3.
- Background: PubMed 31178087Chan AHW, Elhassan BT, Suh N. The Use of the Proximal Hamate as an Autograft for Proximal Pole Scaphoid Fractures: Clinical Outcomes and Biomechanical Implications. Hand Clin. 2019 Aug;35(3):287-294. doi: 10.1016/j.hcl.2019.03.007. Epub 2019 May 11.
- Background: PubMed 34274497Saruhan S, Savran A, Yildiz M, Sener M. Reconstruction of proximal pole scaphoid non-union with avascular necrosis using proximal hamate: A four-case series. Hand Surg Rehabil. 2021 Dec;40(6):744-748. doi: 10.1016/j.hansur.2021.07.003. Epub 2021 Jul 16.
- Background: PubMed 29643522Wang DY, Li X, Shen ZC, Gu PL, Pei YR, Zeng G, Leng HJ, Zhang WG. [Three-dimensional architecture of intraosseous vascular anatomy of the hamate: a micro-computed tomography study]. Beijing Da Xue Xue Bao Yi Xue Ban. 2018 Apr 18;50(2):245-248. Chinese.
- Background: PubMed 29934078Wu K, Padmore C, Lalone E, Suh N. An Anthropometric Assessment of the Proximal Hamate Autograft for Scaphoid Proximal Pole Reconstruction. J Hand Surg Am. 2019 Jan;44(1):60.e1-60.e8. doi: 10.1016/j.jhsa.2018.04.021. Epub 2018 Jun 20.
- Background: PubMed 30124083Kakar S, Greene RM, Hewett T, Thoreson AR, Hooke AW, Elhassan BT. The Effect of Proximal Hamate Osteotomy on Carpal Kinematics for Reconstruction of Proximal Pole Scaphoid Nonunion With Avascular Necrosis. Hand (N Y). 2020 May;15(3):371-377. doi: 10.1177/1558944718793175. Epub 2018 Aug 20.
- Background: PubMed 30017649Sollaccio DR, Navo P, Ghiassi A, Orr CM, Patel BA, Lewton KL. Evaluation of Articular Surface Similarity of Hemi-Hamate Grafts and Proximal Middle Phalanx Morphology: A 3D Geometric Morphometric Approach. J Hand Surg Am. 2019 Feb;44(2):121-128. doi: 10.1016/j.jhsa.2018.06.008. Epub 2018 Jul 14.
- Background: PubMed 31300229Kakar S, Greene RM, Elhassan BT, Holmes DR 3rd. Topographical Analysis of the Hamate for Proximal Pole Scaphoid Nonunion Reconstruction. J Hand Surg Am. 2020 Jan;45(1):69.e1-69.e7. doi: 10.1016/j.jhsa.2019.05.013. Epub 2019 Jul 9.
- Background: PubMed 34109073Thayer MK, Bluth B, Huang JI. A Morphometric Analysis of Hamate Autograft for Proximal Scaphoid Reconstruction. J Wrist Surg. 2021 Jun;10(3):268-271. doi: 10.1055/s-0041-1726404. Epub 2021 Apr 14.
- BackgroundRobinson PG, Duckworth AD, Campbell DA. Acute Fractures in Sport: Wrist. In: Robertson GAJ, Maffulli N, eds. Fractures in Sport. Springer, Cham; 2021:155-174. https://doi.org/10.1007/978-3-030-72036-0_11
- BackgroundSegalman KA, Graham TJ. Scaphoid Proximal Pole fractures and Nonunions. J. Am. Soc. Surg. Hand. 2004;4(4): 233-249. doi:10.1016/j.jassh.2004.09.008
- Individual participant dataSharing planned: No
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.
Ahmed Mohamed Ashraf Abdelfatah Rabie, Orthopedic Surgery Specialist, principal investigator
Ain Shams University
Ayman Ibrahim Fathy Aly Hewaidy, Professor of Orthopedic Surgery, study chair
Faculty of Medicine, Ain Shams University
Ahmed Naeem Atiyya Aly, Professor of Orthopedic Surgery, study director
Faculty of Medicine, 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 Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction in people with Closed Fracture Scaphoid, Proximal Pole and A Proximal Pole of Scaphoid That is Deemed Unsalvageable, 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 2 inclusion and 4 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 25 Oct 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?
Results are not available in the source record.
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 postoperatively). 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 NCT05525988, which also lists 13 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 25 Oct 2022.