Metacarpal Fractures in AdultsNCT06543485
Headless Screw Fixation for Metacarpal Fractures in Adults.
A study testing intramedullary screw fixation of metacarpal fractures in people with Metacarpal Fractures in Adults, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metacarpal Fractures in Adults
- What is being tested?
- intramedullary screw fixation of metacarpal fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2024to 20 Mar 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients.
- Metacarpal shaft fractures.
- Simple fractures.
- Recent fractures within 1-2 weeks.
- Isolated metacarpal fractures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Sohag University
Sohag, Select A State Or Province, 02
Mohannad B Al-Sayed, 01091098002, mohanad4605@gmail.com
About this study
Official title: 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,
- Conditions
- Metacarpal Fractures in Adults
- Being tested
- intramedullary screw fixation of metacarpal fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary screw fixation of metacarpal fracturesProcedure or surgery
intramedullary screw fixation of metacarpal fractures through limited open approach
| Study group | Role | What they receive |
|---|---|---|
| adults with metacarpal fractures | Experimental | intramedullary screw fixation of metacarpal fractures Receives: Procedure: intramedullary screw fixation of metacarpal fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
early active range of motion
QuickDASH score ( Disabilities of the Arm, Shoulder and Hand questionnaire )
Measured: 3 days-12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start25 Aug 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Metacarpal Fractures in AdultsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohannad Bahaa Al-Sayyd, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543485
- Sponsor's protocol ID
- soh-med-24-07-13MS
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24294164Court-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.
PubMed 16814787Karl 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.
PubMed 25714441Chung 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.
PubMed 11561245Page 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.
PubMed 9763256Robinson 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.
PubMed 28236187Siddiqui 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.
PubMed 31249744Botte 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.
PubMed 1537152Stahl 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.
PubMed 11599756Eberlin 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.
PubMed 24996674Hoang 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.
PubMed 33092908
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Intramedullary Headless Screw Fixation for Metacarpal Fractures in Adults.
- ClinicalTrials.gov ID
- NCT06543485
- Acronym / sponsor ID
- soh-med-24-07-13MS
- Conditions
- Metacarpal Fractures in Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults with metacarpal fractures | Experimental | Procedure: intramedullary screw fixation of metacarpal fracturesintramedullary screw fixation of metacarpal fractures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients.
- Metacarpal shaft fractures.
- Simple fractures.
- Recent fractures within 1-2 weeks.
- Isolated metacarpal fractures.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| intramedullary screw fixation of metacarpal fracturesintramedullary screw fixation of metacarpal fractures through limited open approach | Procedure or surgery | adults with metacarpal fractures |
Primary outcome
early active range of motion
Time frame: 3 days-12 weeks after surgery
QuickDASH score ( Disabilities of the Arm, Shoulder and Hand questionnaire )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 24294164Nakashian 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.
- Background: PubMed 16814787Court-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.
- Background: PubMed 25714441Karl 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.
- Background: PubMed 11561245Chung 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.
- Background: PubMed 9763256Page 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.
- Background: PubMed 28236187Robinson 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.
- Background: PubMed 31249744Siddiqui 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.
- Background: PubMed 1537152Botte 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.
- Background: PubMed 11599756Stahl 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.
- Background: PubMed 24996674Eberlin 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.
- Background: PubMed 33092908Hoang 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.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intramedullary screw fixation of metacarpal fractures in people with Metacarpal Fractures in Adults, run by Sohag 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 5 inclusion and 6 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 9 Aug 2024. 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?
Contact Mohannad B Al-Sayed (01091098002, mohanad4605@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early active range of motion (time frame: 3 days-12 weeks after surgery). 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 NCT06543485, which also lists 11 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 9 Aug 2024.