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FACTS: Surgical and non-surgical treatment for hand bone fractures in adults

Fractures of Adult metaCarpal shafTS (FACTS): Surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13922779
Enrollment
84
Registered
2020-07-14
Start date
2020-08-01
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metacarpal shaft fractures of the finger digits in adults Musculoskeletal Diseases Metacarpal shaft fractures

Interventions

This is an observational study. Patients treated in the two participating centres will be recruited to the study. No additional interventions outside of routine care will be undertaken. The outcomes o
assessment of eligibility, recruitment and retention rates
completion of follow-up
evaluation of outcome measures and calculation of the minimal clinically important difference (MCID) for the primary outcome measures using quantitative and qualitative assessments and establishing th
two-way communication - text message requiring a response from th

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults 16 years or older 2. Radiologically confirmed metacarpal shaft fracture 3. Acute metacarpal shaft fracture affecting the index to little finger(s), presenting within 10 days of injury 4. Willing and able to give informed consent 5. Ability to understand English

Exclusion criteria

Exclusion criteria: 1. Fracture(s) of the thumb 2. Fractures extending into the joint surface 3. Fracture(s) of the metaphyseal base and/or neck of the metacarpal 4. Fracture(s) associated with dislocation at the carpometacarpal joint or other adjacent joint dislocation 5. Open fractures 6. Undisplaced fractures, defined as those with a visible fracture line on radiographs but anatomical alignment, i.e. the bone fragments remain aligned with no evidence of movement of the fracture fragments on anteroposterior, lateral or oblique radiographs 7. Patients who would not be able to adhere to study procedures or complete the study questionnaires

Design outcomes

Secondary

MeasureTime frame
1. Hand function at 6 weeks by measuring the range of motion and grip strength 2. X-rays taken as part of routine clinical care will be reviewed at the 6-week research clinic and the location, type of fracture, amount of shortening, angulation and presence of step-off deformity on the X-rays will be recorded. 3. Questionnaires, patient-reported outcome measures, consisting of the hand health profile of the Patient Evaluation Measure (PEM), Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS-UE), Shortened Disabilities of the Arm, Shoulder and Hand Outcome Measure (QuickDASH), European quality of life questionnaire (EQ-5D-5L) and the Global Rating of Change (GROC) scale will be collected at baseline, 6 weeks, 3 months and 6 months

Primary

MeasureTime frame
Feasibility outcomes are: 1. Number and proportion of patients assessed for eligibility 2. Size of the eligible patient pool available for recruitment 3. Identification of primary outcome measures for use in a future RCT 4. Estimation of the minimal clinically important difference (MCID) for selected outcome measures 5. Completion of follow-up assessments 6. Evaluation of the use of text messages in optimising data collection and retention

Countries

England, United Kingdom

Contacts

Public ContactRowa Taha
FACTS-study@nottingham.ac.uk+44 (0) 115 823 1113

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026