- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06543485
Headless Screw Fixation for Metacarpal Fractures in Adults.
August 7, 2024 updated by: Mohannad Bahaa Al-Sayyd, Sohag University
Results of Intramedullary Headless Screw Fixation for Metacarpal Fractures in Adults.
The goal of this study is to evaluate results of intramedullary screw fixation of metacarpal fractures while summarizing the pearls and pitfalls to maximize successful surgical outcomes in adults, Metacarpal fractures are third most common upper extremity fractures, Intramedullary screw Fixation is a fixation option that offers rigid stability, early active range of motion, and simplicity of insertion,
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
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 Contact
- Name: Mohannad B Al-Sayed
- Phone Number: 01091098002
- Email: mohanad4605@gmail.com
Study Locations
-
-
Select A State Or Province
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Sohag, Select A State Or Province, Egypt, 02
- Faculty of medicine sohag university
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Contact:
- Mohannad B Al-Sayed
- Phone Number: 01091098002
- Email: mohanad4605@gmail.com
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult patients.
- Metacarpal shaft fractures.
- Simple fractures.
- Recent fractures within 1-2 weeks.
- Isolated metacarpal fractures.
Exclusion Criteria:
- Pediatric fractures with open physis.
- Head-splitting fractures and Metacarpal basal fractures.
- Compound fracture increasing risk of infection.
- medical illness or mental disorders affecting the follow-up examination.
- Association with other fractures fixed by methods that limit early range of motion.
- pathologic fractures.
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: adults with metacarpal fractures
intramedullary screw fixation of metacarpal fractures
|
intramedullary screw fixation of metacarpal fractures through limited open approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
early active range of motion
Time Frame: 3 days-12 weeks after surgery
|
QuickDASH score ( Disabilities of the Arm, Shoulder and Hand questionnaire )
|
3 days-12 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
- Karl JW, Olson PR, Rosenwasser MP. The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma. 2015 Aug;29(8):e242-4. doi: 10.1097/BOT.0000000000000312.
- Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.
- Nakashian MN, Pointer L, Owens BD, Wolf JM. Incidence of metacarpal fractures in the US population. Hand (N Y). 2012 Dec;7(4):426-30. doi: 10.1007/s11552-012-9442-0.
- Page SM, Stern PJ. Complications and range of motion following plate fixation of metacarpal and phalangeal fractures. J Hand Surg Am. 1998 Sep;23(5):827-32. doi: 10.1016/S0363-5023(98)80157-3.
- Robinson LP, Gaspar MP, Strohl AB, Teplitsky SL, Gandhi SD, Kane PM, Osterman AL. Dorsal versus lateral plate fixation of finger proximal phalangeal fractures: a retrospective study. Arch Orthop Trauma Surg. 2017 Apr;137(4):567-572. doi: 10.1007/s00402-017-2650-x. Epub 2017 Feb 24.
- Siddiqui AA, Kumar J, Jamil M, Adeel M, Kaimkhani GM. Fixation of Metacarpal Fractures Using Intramedullary Headless Compression Screws: A Tertiary Care Institution Experience. Cureus. 2019 Apr 16;11(4):e4466. doi: 10.7759/cureus.4466.
- Botte MJ, Davis JL, Rose BA, von Schroeder HP, Gellman H, Zinberg EM, Abrams RA. Complications of smooth pin fixation of fractures and dislocations in the hand and wrist. Clin Orthop Relat Res. 1992 Mar;(276):194-201.
- Stahl S, Schwartz O. Complications of K-wire fixation of fractures and dislocations in the hand and wrist. Arch Orthop Trauma Surg. 2001 Oct;121(9):527-30. doi: 10.1007/s004020100279.
- Eberlin KR, Babushkina A, Neira JR, Mudgal CS. Outcomes of closed reduction and periarticular pinning of base and shaft fractures of the proximal phalanx. J Hand Surg Am. 2014 Aug;39(8):1524-8. doi: 10.1016/j.jhsa.2014.05.008. Epub 2014 Jul 2.
- Hoang D, Vu CL, Jackson M, Huang JI. An Anatomical Study of Metacarpal Morphology Utilizing CT Scans: Evaluating Parameters for Antegrade Intramedullary Compression Screw Fixation of Metacarpal Fractures. J Hand Surg Am. 2021 Feb;46(2):149.e1-149.e8. doi: 10.1016/j.jhsa.2020.08.007. Epub 2020 Oct 19.
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 (Estimated)
August 25, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
March 20, 2025
Study Registration Dates
First Submitted
July 31, 2024
First Submitted That Met QC Criteria
August 7, 2024
First Posted (Actual)
August 9, 2024
Study Record Updates
Last Update Posted (Actual)
August 9, 2024
Last Update Submitted That Met QC Criteria
August 7, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-med-24-07-13MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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