Primary objective: Is functional treatment (soft wrap and buddy taping) superior in recovering hand function (QuickDASH) compared to casting in patients with uncomplicated subcapital MCV fracture? Secondary objectives: patient satisfaction, grip…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in QuickDASH score after 12 months
Secondary outcome
- How satisfied are patients with treatment with functional treatment or
casting?
- What is the grip strength and ROM at 6 weeks and 6 months?
- Wat are the pain scores at week 0, 1, 3, 6 and month 6?
- How many days till return to work and sports?
- Which complications are seen and how often?
Could include: functional complaints (stiffness, reduced ROM) and
secondary dislocation (x-rays only performed on clinical indication of
attending physician).
- What is the influence of dominance of affected side on above?
Background summary
Uncomplicated subcapital fifth metacarpal (MCV) fractures are common injuries
that are commonly treated with a cast. Functional treatment (buddy tape and/or
compression bandage) might result in quicker recovery of hand function, with
similar outcomes on complications and pain scores. Functional treatment might
benefit patients by quicker recovery, more comfort during treatment and less
need for clinical follow-up appointments. Compared to existing literature, this
study will have follow-up with clinical visits instead of only questionnaires.
Furthermore, no reduction will be allowed to minimize differences in groups.
Our intention is to achieve a greater sample size compared to existing
literature to deliver reliable evidence for superiority of treatment with soft
wrap and buddytape over casting.
Study objective
Primary objective: Is functional treatment (soft wrap and buddy taping)
superior in recovering hand function (QuickDASH) compared to casting in
patients with uncomplicated subcapital MCV fracture? Secondary objectives:
patient satisfaction, grip strength and Range of Motion (ROM), pain scores,
days till return to work/sports and occurrence of complications.
Study design
Multicenter randomized trial, non-blinded for patients and physicians.
Intervention
Intervention group will be treated with 1 week soft wrap (compression bandage)
and buddytape of the 4th and 5th finger, followed by 2 weeks continued
buddytape. Control group will be treated with 3 weeks of ulnar gutter cast
(standard treatment).
Study burden and risks
Standard clinical visits at T=0, 1, 3 and 6 weeks. Additional clinical visit at
month 6 and filling in QuickDASH/PROMIS at month 3. Every visit will include
questionnaires (QuickDASH, PROMIS Upper Extremity v2.0 short form, Michigan
Hand Questionnaire subscales paind and satisfaction) and at 2 visits physical
examination of Range of Motion (ROM) and grip strength. The first visit
questionnaire will include questions on patient characteristics (e.g. age,
dominance, occupation).
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Age >18 years old
- Isolated uncomplicated subcapital MCV fracture
- Understanding of Dutch or English language (written and spoken)
- Informed consent for participating
Exclusion criteria
- Age <18 years
- Bilateral fractures
- Indication for surgery (as decided by attending surgeon)
- Complicated fracture: Open, comminuted, intra-articular, rotation or
angulation >70 degrees
- Other significant injuries (e.g. tendon or neurovascular injury, other
fracture in same limb, polytrauma).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75489.029.20 |