Hand; Fracture, PhalanxHANDFIXNCT06372067
IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures
A study testing Intramedullary screw and Kirschner wire in people with Hand; Fracture, Phalanx, run by McMaster University at 1 site in Canada.
Trial summary
When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand; Fracture, Phalanx
- What is being tested?
- Intramedullary screw and Kirschner wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients ≥18 years old
- scheduled for operative management of extraarticular proximal or middle closed phalanx fracture(s) at the investigators' tertiary hospital
- feasible to perform closed reduction
- able to provide informed consent and complete health-related quality of life (HRQoL) questionnaires in English
Who cannot join
- other fractures that cannot be managed with IM screws or K-wires
- other intraarticular fractures
- significant concomitant hand trauma
- cannot commit to 3 months of follow up at the investigators' institution
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario, l6l5n4
Emily Dunn, MSc, 905-522-1155, dunne4@mcmaster.ca
About this study
Official title: Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures: Pilot Study for a Randomized Controlled Trial
When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work.
Read the detailed description
Hand fractures are one of the most common skeletal injuries and affect a wide range of the population. Commonly affected groups include children and young adults with sports-related injuries, manual labourers with work-related injuries, and the elderly. Although the majority of phalanx fractures may be managed conservatively with good outcomes, operative fixation is indicated for significantly displaced or unstable fracture patterns, and those causing malrotation and scissoring.
There are a variety of options for operative fixation of proximal and middle phalanx fractures, which include closed versus open reduction (CR vs OR) with percutaneous pinning (PP) or internal fixation (IF) techniques. Kirschner wires (K-wire) and plates/screws are the most common CRPP and ORIF techniques. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection. Conversely, ORIF with plates/screws provide rigid fixation allowing for early mobilization, but require opening of fracture site and often periosteal stripping. Complications with ORIF include adhesions and stiffness.
There is emerging evidence for the effectiveness of intramedullary (IM) screw fixation as an alternative technique for IF. IM screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. Its biomechanical properties have been well-described in the lower extremity orthopedic literature. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications. Small observational cohort studies have shown favourable outcomes in return to activity, range of motion, time to radiological healing, and grip strength. However, the investigators' literature search revealed a paucity of high quality studies comparing the effectiveness of IM screws with K-wires or other methods of fixation.
The primary objective of this pilot study is to assess the feasibility of a randomized controlled trial comparing two CR techniques, i.e. IM screw fixation to K-wire fixation, in adult patients with extraarticular proximal or middle phalanx fracture at the investigators' tertiary academic hospital. The secondary objective will be to describe early clinical outcomes which can be used for future trial sample size calculation.
- Conditions
- Hand; Fracture, Phalanx
- Being tested
- Intramedullary screw, Kirschner wire
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary screwDevice
Intramedullary (IM) screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications.
Kirschner wireDevice
Kirschner wire (K-wire) fixation is a minimally invasive technique that provides non-rigid fixation of fractures. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection.
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary screw | Experimental | Intramedullary (IM) screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications. Receives: Device: Intramedullary screw |
| Kirschner wire | Active comparator | Kirschner wire (K-wire) fixation is a minimally invasive technique that provides non-rigid fixation of fractures. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection. Receives: Device: Kirschner wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patient Eligibility - Study Feasibility
The percentage of patients that are eligible for the study among those that are screened will be recorded. This criteria will be determined to be feasible if at least 70% of screened patients are deemed to be eligible.
Measured: 1 year
Recruitment rate - Study Feasibility
The percentage of patients that are enrolled in the study among those determined to be eligible will be recorded. To be considered fully enrolled patients must sign the informed consent form, complete baseline demographic questionnaires, and be randomized to a study arm. This criteria will be determined to be feasible if at least 70% of eligible patients are recruited.
Measured: 1 year
Crossover rate - Study Feasibility
The percentage of patients that crossover to the other arm of the study among those who are eligible and recruited for the study. This criteria will be determined to be feasible if no more than 5% of patients cross over.
Measured: 1 year
Compliance with intervention rate - Study Feasibility
The percentage of patients that comply with the intervention (appropriate post-operative care, follow-up appointments) among those who are eligible and recruited for the study. This criteria will be determined to be feasible if at least 90% of patients are compliant.
Measured: 1 year
Patient retention rate - Study Feasibility
The percentage of patients that complete patient-reported questionnaire (Disabilities of the Arm, Shoulder, and Hand) at the 3-month mark, which will be the primary outcome of the main trial. Scores range from 0-100 points, where higher scores indicate greater disability. This criteria will be determined to be feasible if at least 80% of patients are compliant.
Measured: 1 year
Secondary outcomes (6)
Disability of the Arm, Shoulder, and Hand
The Disability of the Arm, Shoulder, and Hand is a region-specific PROM that has been shown to be valid, reliable, and responsive to change in measuring patient-important domains pertaining to the upper extremity. Scores range from 0-100 points, where higher scores indicate greater disability. In trauma populations, the Disability of the Arm, Shoulder, and Hand has been shown to have excellent internal consistency (0.98) and test-retest probability (intraclass correlation coefficient [ICC] = 0.98). The Disability of the Arm, Shoulder, and Hand has also been reported to have good criterion validity, construct validity and responsiveness in hand trauma patients.
Measured: baseline, 4 weeks, 12 weeks
Range of motion
Range of motion of the affected finger, compared to the contralateral finger. As measured and reported by hand therapist appointments which are part of routine care at the investigators' institution.
Measured: 4 weeks, 8 weeks, 12 weeks
Grip strength
Grip strength of the affected hand, compared to the contralateral hand. As measured and reported by hand therapist appointments which are part of routine care at the investigators' institution.
Measured: 8 weeks, 12 weeks
Return to work
Time of patient-reported return to work or surgeon clearance for return to work.
Measured: through study completion, an average of 3 months
Complications/adverse events
Post-operative complications/adverse events include but are not limited to stiffness, delayed union, non-union, malunion, infection, hardware removal, reoperation.
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Postoperative pain (visual analogue scale)
Pain will be measured postoperative on the visual analogue scale, which ranges from 0-10. Higher scores indicate greater pain.
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hand; Fracture, PhalanxStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, pilot randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Retrouvey, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372067
- Sponsor's protocol ID
- 17378
- Acronym
- HANDFIX
- Status last verified
- May 2025
- First submitted
- 12 Apr 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individualized participant data will not be shared.
Publications
Meals C, Meals R. Hand fractures: a review of current treatment strategies. J Hand Surg Am. 2013 May;38(5):1021-31; quiz 1031. doi: 10.1016/j.jhsa.2013.02.017.
PubMed 23618458Kremer L, Frank J, Lustenberger T, Marzi I, Sander AL. Epidemiology and treatment of phalangeal fractures: conservative treatment is the predominant therapeutic concept. Eur J Trauma Emerg Surg. 2022 Feb;48(1):567-571. doi: 10.1007/s00068-020-01397-y. Epub 2020 May 25.
PubMed 32451567Gaio NM, Kruse LM. Closed Reduction Percutaneous Pinning Versus Open Reduction With Plate and Screw Fixation in Management of Unstable Proximal Phalangeal Fractures: A Systematic Review and Meta-analysis. Hand (N Y). 2025 Jan;20(1):136-142. doi: 10.1177/15589447231189762. Epub 2023 Aug 20.
PubMed 37599408Chao J, Patel A, Shah A. Intramedullary Screw Fixation Comprehensive Technique Guide for Metacarpal and Phalanx Fractures: Pearls and Pitfalls. Plast Reconstr Surg Glob Open. 2021 Oct 26;9(10):e3895. doi: 10.1097/GOX.0000000000003895. eCollection 2021 Oct.
PubMed 34712548Bong MR, Kummer FJ, Koval KJ, Egol KA. Intramedullary nailing of the lower extremity: biomechanics and biology. J Am Acad Orthop Surg. 2007 Feb;15(2):97-106. doi: 10.5435/00124635-200702000-00004.
PubMed 17277256del Pinal F, Moraleda E, Ruas JS, de Piero GH, Cerezal L. Minimally invasive fixation of fractures of the phalanges and metacarpals with intramedullary cannulated headless compression screws. J Hand Surg Am. 2015 Apr;40(4):692-700. doi: 10.1016/j.jhsa.2014.11.023. Epub 2015 Feb 7.
PubMed 25661294Patankar H, Meman FW. Multiple intramedullary nailing of proximal phalangeal fractures of hand. Indian J Orthop. 2008 Jul;42(3):342-6. doi: 10.4103/0019-5413.39573.
PubMed 19753163Verver D, Timmermans L, Klaassen RA, van der Vlies CH, Vos DI, Schep NWL. Treatment of extra-articular proximal and middle phalangeal fractures of the hand: a systematic review. Strategies Trauma Limb Reconstr. 2017 Aug;12(2):63-76. doi: 10.1007/s11751-017-0279-5. Epub 2017 Mar 4.
PubMed 28260179Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223Deshmukh SR, Mousoulis C, Marson BA, Grindlay D, Karantana A; Core Outcome Set for Hand Fractures and Joint Injuries in Adults Group*. Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review. J Hand Surg Eur Vol. 2021 Jun;46(5):488-495. doi: 10.1177/1753193420983719. Epub 2021 Jan 24.
PubMed 33487059Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
PubMed 12809562Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
PubMed 11382253Ziebart C, Bobos P, Furtado R, Dabbagh A, MacDermid J. Patient-reported outcome measures used for hand and wrist disorders: An overview of systematic reviews. J Hand Ther. 2023 Jul-Sep;36(3):719-729. doi: 10.1016/j.jht.2022.10.007. Epub 2023 Mar 11.
PubMed 36914499Esteban-Feliu I, Gallardo-Calero I, Barrera-Ochoa S, Lluch-Bergada A, Alabau-Rodriguez S, Mir-Bullo X. Analysis of 3 Different Operative Techniques for Extra-articular Fractures of the Phalanges and Metacarpals. Hand (N Y). 2021 Sep;16(5):595-603. doi: 10.1177/1558944719873144. Epub 2019 Sep 13.
PubMed 31517524
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures: Pilot Study for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06372067
- Acronym / sponsor ID
- HANDFIX / 17378
- Conditions
- Hand; Fracture, Phalanx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 17 Apr 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.
When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work.
Detailed description
Hand fractures are one of the most common skeletal injuries and affect a wide range of the population. Commonly affected groups include children and young adults with sports-related injuries, manual labourers with work-related injuries, and the elderly. Although the majority of phalanx fractures may be managed conservatively with good outcomes, operative fixation is indicated for significantly displaced or unstable fracture patterns, and those causing malrotation and scissoring.
There are a variety of options for operative fixation of proximal and middle phalanx fractures, which include closed versus open reduction (CR vs OR) with percutaneous pinning (PP) or internal fixation (IF) techniques. Kirschner wires (K-wire) and plates/screws are the most common CRPP and ORIF techniques. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection. Conversely, ORIF with plates/screws provide rigid fixation allowing for early mobilization, but require opening of fracture site and often periosteal stripping. Complications with ORIF include adhesions and stiffness.
There is emerging evidence for the effectiveness of intramedullary (IM) screw fixation as an alternative technique for IF. IM screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. Its biomechanical properties have been well-described in the lower extremity orthopedic literature. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications. Small observational cohort studies have shown favourable outcomes in return to activity, range of motion, time to radiological healing, and grip strength. However, the investigators' literature search revealed a paucity of high quality studies comparing the effectiveness of IM screws with K-wires or other methods of fixation.
The primary objective of this pilot study is to assess the feasibility of a randomized controlled trial comparing two CR techniques, i.e. IM screw fixation to K-wire fixation, in adult patients with extraarticular proximal or middle phalanx fracture at the investigators' tertiary academic hospital. The secondary objective will be to describe early clinical outcomes which can be used for future trial sample size calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, open-label, pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intramedullary screw | Experimental | Device: Intramedullary screwIntramedullary (IM) screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications. |
| Kirschner wire | Active comparator | Device: Kirschner wireKirschner wire (K-wire) fixation is a minimally invasive technique that provides non-rigid fixation of fractures. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients ≥18 years old
- scheduled for operative management of extraarticular proximal or middle closed phalanx fracture(s) at the investigators' tertiary hospital
- feasible to perform closed reduction
- able to provide informed consent and complete health-related quality of life (HRQoL) questionnaires in English
Key exclusion criteria (4 listed)
- other fractures that cannot be managed with IM screws or K-wires
- other intraarticular fractures
- significant concomitant hand trauma
- cannot commit to 3 months of follow up at the investigators' institution
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 screwIntramedullary (IM) screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications. | Device | Intramedullary screw |
| Kirschner wireKirschner wire (K-wire) fixation is a minimally invasive technique that provides non-rigid fixation of fractures. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection. | Device | Kirschner wire |
Primary outcome
Percentage of Patient Eligibility - Study Feasibility
Time frame: 1 year
The percentage of patients that are eligible for the study among those that are screened will be recorded. This criteria will be determined to be feasible if at least 70% of screened patients are deemed to be eligible.
Recruitment rate - Study Feasibility
Time frame: 1 year
The percentage of patients that are enrolled in the study among those determined to be eligible will be recorded. To be considered fully enrolled patients must sign the informed consent form, complete baseline demographic questionnaires, and be randomized to a study arm. This criteria will be determined to be feasible if at least 70% of eligible patients are recruited.
Crossover rate - Study Feasibility
Time frame: 1 year
The percentage of patients that crossover to the other arm of the study among those who are eligible and recruited for the study. This criteria will be determined to be feasible if no more than 5% of patients cross over.
Compliance with intervention rate - Study Feasibility
Time frame: 1 year
The percentage of patients that comply with the intervention (appropriate post-operative care, follow-up appointments) among those who are eligible and recruited for the study. This criteria will be determined to be feasible if at least 90% of patients are compliant.
Patient retention rate - Study Feasibility
Time frame: 1 year
The percentage of patients that complete patient-reported questionnaire (Disabilities of the Arm, Shoulder, and Hand) at the 3-month mark, which will be the primary outcome of the main trial. Scores range from 0-100 points, where higher scores indicate greater disability. This criteria will be determined to be feasible if at least 80% of patients are compliant.
6 secondary outcomes
Disability of the Arm, Shoulder, and Hand
Time frame: baseline, 4 weeks, 12 weeks
Range of motion
Time frame: 4 weeks, 8 weeks, 12 weeks
Grip strength
Time frame: 8 weeks, 12 weeks
Return to work
Time frame: through study completion, an average of 3 months
Complications/adverse events
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Postoperative pain (visual analogue scale)
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 23618458Meals C, Meals R. Hand fractures: a review of current treatment strategies. J Hand Surg Am. 2013 May;38(5):1021-31; quiz 1031. doi: 10.1016/j.jhsa.2013.02.017.
- Background: PubMed 32451567Kremer L, Frank J, Lustenberger T, Marzi I, Sander AL. Epidemiology and treatment of phalangeal fractures: conservative treatment is the predominant therapeutic concept. Eur J Trauma Emerg Surg. 2022 Feb;48(1):567-571. doi: 10.1007/s00068-020-01397-y. Epub 2020 May 25.
- Background: PubMed 37599408Gaio NM, Kruse LM. Closed Reduction Percutaneous Pinning Versus Open Reduction With Plate and Screw Fixation in Management of Unstable Proximal Phalangeal Fractures: A Systematic Review and Meta-analysis. Hand (N Y). 2025 Jan;20(1):136-142. doi: 10.1177/15589447231189762. Epub 2023 Aug 20.
- Background: PubMed 34712548Chao J, Patel A, Shah A. Intramedullary Screw Fixation Comprehensive Technique Guide for Metacarpal and Phalanx Fractures: Pearls and Pitfalls. Plast Reconstr Surg Glob Open. 2021 Oct 26;9(10):e3895. doi: 10.1097/GOX.0000000000003895. eCollection 2021 Oct.
- Background: PubMed 17277256Bong MR, Kummer FJ, Koval KJ, Egol KA. Intramedullary nailing of the lower extremity: biomechanics and biology. J Am Acad Orthop Surg. 2007 Feb;15(2):97-106. doi: 10.5435/00124635-200702000-00004.
- Background: PubMed 25661294del Pinal F, Moraleda E, Ruas JS, de Piero GH, Cerezal L. Minimally invasive fixation of fractures of the phalanges and metacarpals with intramedullary cannulated headless compression screws. J Hand Surg Am. 2015 Apr;40(4):692-700. doi: 10.1016/j.jhsa.2014.11.023. Epub 2015 Feb 7.
- Background: PubMed 19753163Patankar H, Meman FW. Multiple intramedullary nailing of proximal phalangeal fractures of hand. Indian J Orthop. 2008 Jul;42(3):342-6. doi: 10.4103/0019-5413.39573.
- Background: PubMed 28260179Verver D, Timmermans L, Klaassen RA, van der Vlies CH, Vos DI, Schep NWL. Treatment of extra-articular proximal and middle phalangeal fractures of the hand: a systematic review. Strategies Trauma Limb Reconstr. 2017 Aug;12(2):63-76. doi: 10.1007/s11751-017-0279-5. Epub 2017 Mar 4.
- Background: PubMed 20053272Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
- Background: PubMed 27777223Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
- Background: PubMed 33487059Deshmukh SR, Mousoulis C, Marson BA, Grindlay D, Karantana A; Core Outcome Set for Hand Fractures and Joint Injuries in Adults Group*. Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review. J Hand Surg Eur Vol. 2021 Jun;46(5):488-495. doi: 10.1177/1753193420983719. Epub 2021 Jan 24.
- Background: PubMed 12809562Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
- Individual participant dataSharing planned: No. Individualized participant data will not be shared.
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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.
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 and Kirschner wire in people with Hand; Fracture, Phalanx, run by McMaster University at 1 site in Canada.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patient Eligibility - Study Feasibility (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT06372067, which also lists 15 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 22 Jul 2025.