IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures (HANDFIX)

• ClinicalTrials.gov Identifier: NCT06372067
• Recruitment Status: Not yet recruiting
• First Posted: April 17, 2024
• Last Update Posted: April 17, 2024
• Sponsor: McMaster University
• Information provided by (Responsible Party): Helene Retrouvey, McMaster University

Tracking Information

• First Submitted Date: April 12, 2024
• First Posted Date: April 17, 2024
• Last Update Posted Date: April 17, 2024
• Estimated Study Start Date: July 1, 2024
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2024)

• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 16, 2024)

• Disability of the Arm, Shoulder, and Hand [ Time Frame: baseline, 4 weeks, 12 weeks ]
  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.
• Range of motion [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
  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.
• Grip strength [ Time Frame: 8 weeks, 12 weeks ]
  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.
• Return to work [ Time Frame: through study completion, an average of 3 months ]
  Time of patient-reported return to work or surgeon clearance for return to work.
• Complications/adverse events [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks ]
  Post-operative complications/adverse events include but are not limited to stiffness, delayed union, non-union, malunion, infection, hardware removal, reoperation.
• Postoperative pain (visual analogue scale) [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks ]
  Pain will be measured postoperative on the visual analogue scale, which ranges from 0-10. Higher scores indicate greater pain.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures
• Official Title: Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures: Pilot Study for a Randomized Controlled Trial
• Brief 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. 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, open-label, pilot randomized controlled trial

Masking: Single (Outcomes Assessor)
Masking Description:

By nature of the interventions in this study, blinding will not be possible for the surgeon or the patient post-operatively.

Primary Purpose: Treatment

• Condition: Hand; Fracture, Phalanx

Intervention

• Device: Intramedullary screw
  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.
• Device: Kirschner wire
  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 Arms

• Experimental: Intramedullary screw
  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.
  Intervention: Device: Intramedullary screw
• Active Comparator: Kirschner wire
  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.
  Intervention: Device: Kirschner wire

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.
• Kremer 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.
• Gaio 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). 2023 Aug 20:15589447231189762. doi: 10.1177/15589447231189762. Online ahead of print.
• Chao 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.
• Bong 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.
• del 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.
• Patankar 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.
• Verver 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.
• Thabane 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. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59.
• Eldridge 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.
• Deshmukh 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 Jan 24:1753193420983719. doi: 10.1177/1753193420983719. Online ahead of print.
• Gummesson 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.
• Beaton 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.
• Ziebart 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.
• Esteban-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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 16, 2024): 34
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2026
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. adult patients ≥18 years old
2. scheduled for operative management of extraarticular proximal or middle closed phalanx fracture at the investigators' tertiary hospital
3. feasible to perform closed reduction
4. able to provide informed consent and complete health-related quality of life (HRQoL) questionnaires in English

Exclusion Criteria:

1. multiple fractured fingers
2. significant concomitant hand trauma
3. cannot commit to 3 months of follow up at the investigators' institution

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06372067
• Other Study ID Numbers: 17378
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Individualized participant data will not be shared.

• Current Responsible Party: Helene Retrouvey, McMaster University
• Original Responsible Party: Same as current
• Current Study Sponsor: McMaster University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: McMaster University
• Verification Date: April 2024