Proximal Pole Scaphoid Reconstruction Using Proximal Hamate

October 23, 2022 updated by: Ain Shams University

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:

  1. Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique.
  2. Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function.
  3. Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.

Study Overview

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:

  1. Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique.
  2. Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function.
  3. Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Greater Cairo
      • Cairo, Greater Cairo, Egypt, 11591
        • AIN shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemi-Hamate Graft for Proximal Pole Scaphoid Reconstruction
[All participants enrolled in this study for proximal pole scaphoid reconstruction using the Hemi-Hamate autograft]

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.]
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Union
Time Frame: A 6 months postoperatively
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.]
A 6 months postoperatively
Complications
Time Frame: Intraoperatively to 1-year postoperatively
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.
Intraoperatively to 1-year postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion (ROM) of the Wrist
Time Frame: Preoperatively and 1-year postoperatively
Evaluated by recording the (ROM) of the operated wrist using a goniometer
Preoperatively and 1-year postoperatively
Mayo Wrist Score (MWS)
Time Frame: Preoperatively and 1-year postoperatively
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.
Preoperatively and 1-year postoperatively
The Patient Rated Wrist Evaluation (PRWE) sore
Time Frame: Preoperatively and 1-year postoperatively

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).

Preoperatively and 1-year postoperatively
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: Preoperatively and 1-year postoperatively
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.
Preoperatively and 1-year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ahmed Mohamed Ashraf Abdelfatah Rabie, Orthopedic Surgery Specialist,, AIN shams university
  • Study Chair: Ayman Ibrahim Fathy Aly Hewaidy, Professor of Orthopedic Surgery,, Faculty of Medicine, Ain Shams University
  • Study Director: Ahmed Naeem Atiyya Aly, Professor of Orthopedic Surgery,, Faculty of Medicine, Ain Shams University
  • Study Director: Amr Mostafa Mohamed Aly, Assistant Professor of Orthopedic Surgery,, Faculty of Medicine, Ain Shams University
  • Study Director: Ramy Ahmed Aly Soliman, Lecturer of Orthopedic Surgery,, Faculty of Medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 23, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 38/2022_FWA 00017585

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Closed Fracture Scaphoid, Proximal Pole

Subscribe