Clinical trial NCT04001062: Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures
Official title: Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metacarpal Fracture
Keywords: Metacarpal Shaft Fracture
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Research Objectives:

The goal of this study is to compare the treatment of outcomes for the nonoperative vs. surgical treatment of isolated closed acute non-thumb metacarpal shaft fracture.

a. Primary Measure: i. Functional outcome: Patient Reported Outcomes, including VAS, PROMIS, DASH (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) b. Secondary Measures: i. Grip Strength (6 weeks, 3 months, 6 months) ii. Extensor Lag (degrees) (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) iii. Composite range of motion (pulp to palm distance) (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) iv. Radiographic metacarpal shortening (at each visit) v. Malrotation (scissoring/gapping) (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) vi. Timing of clinical union (lack of tenderness on palpation or stress) vii. Timing of radiographic union (bony bridging across fracture site)

Study Design:

1. 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, and the physician will not select which group the patient is in.
2. Pre-operatively, the patient will have the following standard of care procedures:

   1. Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS),
   2. Radiographic measurement of metacarpal shortening
   3. Range of Motion Measurements
   4. Malrotation (scissoring/gapping) measurement
3. Pre-operatively, the patient will have the following procedures as research only:

   a. Disabilities of the Arm, Shoulder and Hand survey (DASH)
4. Surgical Treatment vs. Non-Surgical Treatment Groups

   1. For non-operatively addressed scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range active range of motion (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 non-operatively addressed non-scissoring injuries: Placement of short-arm cast; immediate active range of motion (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.
   3. For surgical fixation: The surgeon will utilize either pinning, dorsal plate, or lag screws. This will be determined by surgeon expertise while intra-op. Postoperative volar short arm splint, immediate active range of motion (AROM) at full range with buddy taping to adjacent digit. Transition to removable short arm splint at week 2 after suture removal. No strengthening until clinical union.
5. Post-operatively, the patient will have the following standard of care procedures at the 2 week, 6 week, 3 month and 6 month time points:

   1. Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS)
   2. Radiographic measurement of metacarpal shortening
   3. Range of Motion Measurements
   4. Malrotation (scissoring/gapping) measurement
   5. Grip Strength (at 6 week, 3 month, and 6 month follow-ups only)
   6. Notation of timing of clinical union based upon the lack of tenderness on palpation or stress
   7. Notation of the timing of radiographic union, based on bony bridging across the fracture site
6. Post-operatively, the patient will have the following research only procedures at the 2 week, 6 week, 3 month and 6 month time points:

   a. Disabilities of the Arm, Shoulder and Hand survey (DASH)
7. Treatment failure is defined as non-union. Patients may be removed from the study if they are unable to comply with post-operative requirements, or if their injuries are found to be more complex than the study allows for.
8. If patients are removed from the study prematurely, their treatment will continue as standard of care with their attending physician.

Potential Risks:

A potential risk of this treatment is that a patient will experience a non-union or malunion. This is a normal risk of non-thumb metacarpal fracture.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Vas Pain Score
timeFrame: 6 months
measure: PROMIS score
timeFrame: 6 months
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 6 months
measure: Grip Strength
timeFrame: 6 months
measure: Extension lag
timeFrame: 6 months
measure: Finger Range of Motion
timeFrame: 6 months
measure: Time to union
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jay Bridgeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.