An interventional study of Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction in Closed Fracture Scaphoid, Proximal Pole and A Proximal Pole of Scaphoid That is Deemed Unsalvageable, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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:
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:
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's enrollment of 6 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
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Exclusion Criteria:
\[All participants enrolled in this study for proximal pole scaphoid reconstruction using the Hemi-Hamate autograft\]
Procedure: Hemi-Hamate Transfer for Proximal Pole Scaphoid Reconstruction
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.
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. \[Done at the 6-week post-operative clinic visit to assess for the bone union and will be performed in monthly intervals till the bony union.\]
Time frame: 6 months postoperatively
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. \[Done at the 6-week post-operative clinic visit to assess for the bone union and will be performed in monthly intervals till the bony union.\]
Time frame: 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.
Time frame: Intraoperatively to 1-year postoperatively
Range of Motion (ROM) of the Wrist
Evaluated by recording the (ROM) of the operated wrist using a goniometer
Time frame: Preoperatively and 1-year postoperatively
Mayo Wrist Score (MWS)
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
The Patient Rated Wrist Evaluation (PRWE) sore
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: 1. PAIN subscale (0 = no pain, 10 = worst ever) Pain - 5 items \[Pain Score = Sum of the 5 pain items (out of 50)\] 2. 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
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
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
Plan to share: No
Ran from Mar 2022 to primary completion in Sep 2022, 6 months.
Of 14 interventional studies with no phase under Fractures, Closed, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 49. This study's 6 months is below that.
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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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