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

Not Applicable

Terminated

• Conditions: Metacarpal Fracture
• Interventions: Procedure: Surgical Fixation; Other: Non-Operative Management

• Registration Number: NCT04001062
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-operatively	Surgical Fixation	1. Adults 18 and older 2. Native English-speaker 3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)
Surgical	Non-Operative Management	1. Adults 18 and older 2. Native English-speaker 3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)

Primary Outcome Measures

Name	Time	Method
PROMIS score	6 months	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).
Adverse events	6 months	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).
Vas Pain Score	6 months	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."
Disabilities of the Arm, Shoulder and Hand (DASH)	6 months	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.
Grip Strength	6 months	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
Extension lag	6 months	Measured with a goniometer and expressed in degrees (°)
Finger Range of Motion	6 months	Measured with a goniometer and expressed in degrees (°)
Time to union	6 months	Time to achieve clinical and radiologic formation of a stable callus, documented in days

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States