Proximal Pole Scaphoid Reconstruction Using Proximal Hamate
Primary Purpose
Closed Fracture Scaphoid, Proximal Pole, A Proximal Pole of Scaphoid That is Deemed Unsalvageable
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Closed Fracture Scaphoid, Proximal Pole focused on measuring Proximal Pole Scaphoid Reconstruction, Hemi-Hamate Graft
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemi-Hamate Graft for Proximal Pole Scaphoid Reconstruction
Arm Description
[All participants enrolled in this study for proximal pole scaphoid reconstruction using the Hemi-Hamate autograft]
Outcomes
Primary Outcome Measures
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.]
Secondary Outcome Measures
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.]
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05525988
Brief Title
Proximal Pole Scaphoid Reconstruction Using Proximal Hamate
Official Title
Proximal Pole Scaphoid Reconstruction Using Proximal Hamate: Case-Series on A Novel Technique
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture Scaphoid, Proximal Pole, A Proximal Pole of Scaphoid That is Deemed Unsalvageable
Keywords
Proximal Pole Scaphoid Reconstruction, Hemi-Hamate Graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemi-Hamate Graft for Proximal Pole Scaphoid Reconstruction
Arm Type
Experimental
Arm Description
[All participants enrolled in this study for proximal pole scaphoid reconstruction using the Hemi-Hamate autograft]
Intervention Type
Procedure
Intervention Name(s)
Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Union Rate
Description
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.]
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
Time to Union
Description
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.]
Time Frame
A 6 months postoperatively
Title
Complications
Description
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.
Time Frame
Intraoperatively to 1-year postoperatively
Other Pre-specified Outcome Measures:
Title
Range of Motion (ROM) of the Wrist
Description
Evaluated by recording the (ROM) of the operated wrist using a goniometer
Time Frame
Preoperatively and 1-year postoperatively
Title
Mayo Wrist Score (MWS)
Description
The Modified Mayo Wrist Score requires both patient and physician participation in order to assess pain, the active flexion/extension arc (in comparison with the contralateral side), grip strength (in comparison with the contralateral side), and the ability to return to regular employment or activities. Scores range from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition.
Time Frame
Preoperatively and 1-year postoperatively
Title
The Patient Rated Wrist Evaluation (PRWE) sore
Description
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
PAIN subscale (0 = no pain, 10 = worst ever)
Pain - 5 items [Pain Score = Sum of the 5 pain items (out of 50)]
FUNCTION subscale (0 = no difficulty, 10 = unable to do)
Specific activities (6 items) and Usual activities (4 items) [Function Score = Sum of the 10 function items, Divided by 2 (out of 50)]
Computing the Total Score: Total Score = Sum of pain + function scores
Interpretation: Higher score indicates more pain and functional disability (e.g., 0 = no disability).
Time Frame
Preoperatively and 1-year postoperatively
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Description
The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Time Frame
Preoperatively and 1-year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Ashraf Abdelfatah Rabie, Orthopedic Surgery Specialist,
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayman Ibrahim Fathy Aly Hewaidy, Professor of Orthopedic Surgery,
Organizational Affiliation
Faculty of Medicine, Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Naeem Atiyya Aly, Professor of Orthopedic Surgery,
Organizational Affiliation
Faculty of Medicine, Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amr Mostafa Mohamed Aly, Assistant Professor of Orthopedic Surgery,
Organizational Affiliation
Faculty of Medicine, Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ramy Ahmed Aly Soliman, Lecturer of Orthopedic Surgery,
Organizational Affiliation
Faculty of Medicine, Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Greater Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
PubMed Identifier
28149221
Citation
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.
Results Reference
background
PubMed Identifier
31178087
Citation
Chan 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.
Results Reference
background
PubMed Identifier
34274497
Citation
Saruhan 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.
Results Reference
background
PubMed Identifier
29643522
Citation
Wang 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.
Results Reference
background
PubMed Identifier
29934078
Citation
Wu 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.
Results Reference
background
PubMed Identifier
30124083
Citation
Kakar 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.
Results Reference
background
PubMed Identifier
30017649
Citation
Sollaccio 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.
Results Reference
background
PubMed Identifier
31300229
Citation
Kakar 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.
Results Reference
background
PubMed Identifier
34109073
Citation
Thayer 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.
Results Reference
background
Citation
Robinson 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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Links:
URL
https://www.aaos.org/videos/video-detail-page/25577__Videos?fbclid=IwAR1XI-5TE0Fo_31QxvIrY6aalhOiaazHtIZb9qNY27OjOWReEJ4PmgzGQ-w
Description
Proximal Pole Scaphoid Reconstruction Using a Hamate Osteoarticular Autograft video for the surgical technique published by David V Tuckman, MD, FAAOS on Published June 16, 2022
Learn more about this trial
Proximal Pole Scaphoid Reconstruction Using Proximal Hamate
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