Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures

NCT04001062 | Terminated

• 1 other identifier: 2014561
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

There is a lack of strong evidence guiding the treatment of non-thumb isolated closed metacarpal shaft fractures towards operative fixation versus conservative management. Surgical approach is largely decided by surgeon preference/skill, qualities of fracture, and extent of injury. Previous studies have shown that many metacarpal fractures can be treated non-operatively, with outcomes being as good as or better than those treated with surgery. Surgery using plates can often cause stiffness, contractures, and in rare causes nonunion infection or tendon rupture. This study will seek to build upon previous evidence to help guide future surgeons as they decide how to approach a closed non-thumb metacarpal fractures. Patients will be identified in clinic after x-rays are positive for a non-thumb metacarpal fracture. If they consent to participate in the study, they will be put into either the non-operative or surgical group. This decision will be done through randomization.The investigators anticipate that 100 subjects will be enrolled. Patient reported outcomes, including the PROMIS forms, Disabilities of the Arm, Shoulder and Hand (DASH) surveys and Visual Analog Scale (VAS) will be recorded. Range of motion will be assessed at all time points along with grip strength. X-rays will be evaluated for metacarpal shortening, rotation or non-union. In addition, time for clinical and radiologic union will be documented.

Conditions

Metacarpal Fracture

Keywords

Metacarpal Shaft Fracture

Outcome Measures

Primary Outcomes (8)

• Vas Pain Score

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 being "no pain" and 10 being "worst pain."

  6 months

• PROMIS score

  The Patient-Reported Outcomes Measurement Information System® (PROMIS) is a flexible set of tools designed to measure self-reported physical, mental and social health and wellbeing. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The questionnarie assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Norm-based scores are calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).

  6 months

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  6 months

• Grip Strength

  Grip strength will be measured using a Hand Dynamometer with the participants seated, their elbow by their side and flexed to right angles, and a neutral wrist position, the dynamometer handle position II and provision of support underneath the dynamometer. Pressure will be reported in pounds / Kilograms of pressure

  6 months

• Extension lag

  Measured with a goniometer and expressed in degrees (°)

  6 months

• Finger Range of Motion

  Measured with a goniometer and expressed in degrees (°)

  6 months

• Time to union

  Time to achieve clinical and radiologic formation of a stable callus, documented in days

  6 months

• Adverse events

  Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: Severity; Unanticipated Adverse Device Effect (UADE) Seriousness (Serious Adverse Event (SAE), Non-serious AE); Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).

  6 months

Study Arms (2)

Non-operatively

ACTIVE COMPARATOR

1. Adults 18 and older 2. Native English-speaker 3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)

Procedure: Surgical Fixation

Surgical

ACTIVE COMPARATOR

1. Adults 18 and older 2. Native English-speaker 3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)

Other: Non-Operative Management

Interventions

Surgical Fixation PROCEDURE

For both scissoring and non-scissoring injuries surgical fixation by either pinning, dorsal plate, or lag screws will be considered. This will be determined by surgeon expertise at the time of surgical fixation. Postoperative, a volar short arm splint and immediate AROM at full range with buddy taping to adjacent digit will be indicated. Transition to removable short arm splint at week 2 after suture removal. No strengthening until clinical union.

Also known as: Fracture Fixation

Non-operatively

Non-Operative Management OTHER

1. For non-scissoring injuries: Placement of short-arm cast; immediate AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of \<2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union. 2. For scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of \<2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union

Also known as: Conservative Management

Surgical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 and older
• Native English-speaker
• Non-thumb isolated single metacarpal shaft closed fracture

You may not qualify if:

• Pre-existing condition in the involved hand/wrist, hand contracture or deformity, pre-existing stiffness
• Cognitive dysfunction with inability to follow rehabilitation protocol
• Subacute/chronic fracture (\>4 weeks)
• Pregnant Participants
• VA patients

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (7)

• Macdonald BB, Higgins A, Kean S, Smith C, Lalonde DH. Long-term follow-up of unoperated, nonscissoring spiral metacarpal fractures. Plast Surg (Oakv). 2014 Winter;22(4):254-8. doi: 10.4172/plastic-surgery.1000888.

  PMID: 25535464 BACKGROUND

• Eglseder WA Jr, Juliano PJ, Roure R. Fractures of the fourth metacarpal. J Orthop Trauma. 1997 Aug;11(6):441-5. doi: 10.1097/00005131-199708000-00014.

  PMID: 9314153 BACKGROUND

• Al-Qattan MM. Outcome of conservative management of spiral/long oblique fractures of the metacarpal shaft of the fingers using a palmar wrist splint and immediate mobilisation of the fingers. J Hand Surg Eur Vol. 2008 Dec;33(6):723-7. doi: 10.1177/1753193408093559. Epub 2008 Jul 28.

  PMID: 18662959 BACKGROUND

• Westbrook AP, Davis TR, Armstrong D, Burke FD. The clinical significance of malunion of fractures of the neck and shaft of the little finger metacarpal. J Hand Surg Eur Vol. 2008 Dec;33(6):732-9. doi: 10.1177/1753193408092497. Epub 2008 Oct 20.

  PMID: 18936129 BACKGROUND

• Kollitz KM, Hammert WC, Vedder NB, Huang JI. Metacarpal fractures: treatment and complications. Hand (N Y). 2014 Mar;9(1):16-23. doi: 10.1007/s11552-013-9562-1.

  PMID: 24570632 BACKGROUND

• Giddins GE. The non-operative management of hand fractures. J Hand Surg Eur Vol. 2015 Jan;40(1):33-41. doi: 10.1177/1753193414548170. Epub 2014 Sep 12.

  PMID: 25217094 RESULT

• Khan A, Giddins G. The outcome of conservative treatment of spiral metacarpal fractures and the role of the deep transverse metacarpal ligaments in stabilizing these injuries. J Hand Surg Eur Vol. 2015 Jan;40(1):59-62. doi: 10.1177/1753193414540408. Epub 2014 Jun 23.

  PMID: 24963083 RESULT

MeSH Terms

Interventions

Surgical Fixation Devices; Fracture Fixation; Conservative Treatment

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jay Bridgeman, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 27, 2019
• Study Start: June 12, 2019
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)