This prospective randomised controlled trial makes a comparison between four treatment regiments for mallet injuries without fracture: 1. 6 weeks Stack splint followed by free mobilisation (curent standard splint treatment in ost of the hospitals)2…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pees letsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At the end of therapy and at 3 months post-therapy, range of motion and
extension lag is measured by the same examiner (EA) with a goniometer and
compared with the contralateral digit. The skin and nails are examined for
deformities and laceration. Stiffness and pain of the digit is noted. Patient
Evaluation Measure (PEM) forms are used to asses participants* satisfaction.
Secondary outcome
nvt
Background summary
In a mallet deformity the distal interphalangeal (DIP) joint is unable to
extend fully because of disruption of the extensor apparatus at the base of the
distal phalanx. In conservative treatment a mallet splints is used. Currently
there is not enough evidence to show which splint is the superior treatment for
mallet deformity. The success rate is between 40-72%, depending on splint and
treatment regiment used. Hand therapy is also perceived to add to results due
to structured rehabilitation program and improvement of patients compliance.
Study objective
This prospective randomised controlled trial makes a comparison between four
treatment regiments for mallet injuries without fracture:
1. 6 weeks Stack splint followed by free mobilisation (curent standard splint
treatment in ost of the hospitals)
2. 6 weeks Stack splint followed by hand therapy with gradual increase of range
of motion (ROM).
3. 6 weeks Rotterdam (R) splint followed by free mobilisation
4. 6 weeks Rotterdam (R) splint (adjusted splint, which is used in a few
hospitals, e.g. Erasmus University Academical Hospital, with very good results)
followed by hand therapy with gradual increase of ROM.
Study design
The patients are prospectively randomly assigned to one of four groups of 40
patients each:
All patients are examined the same day by the first author (E.A.). The
extension deficit and ROM of the DIP and PIP joint is measured with a
goniometer in a standard way. Patient characteristics like hand dominance,
occupation, age, gender, and ROM of the contralateral corresponding digit is
measured and noted.
Intervention
Patients are treated with standard therapy (= Stack splint), standard therapy
with additional hand therapy, perceived/ presumed improved splint (= R splint)
with additional hand therapy, or perceived/ presumed improved splint (= R
splint) with additional hand therapy.
Study burden and risks
Patients undergo the same therapy which is already used nowadays. Extra burden
for the patient is the extra outpatient clinic visit that has to be done three
months post-therapy. Also a short questionnaire should be completed which takes
about five minutes time. When the R splint proves better, improvement of
therapy for all future patients with mallet type extensor tendon injury can be
provided.
Wilhelminalaan 12, huisnummer 041
1815 JD Alkmaar
Nederland
Wilhelminalaan 12, huisnummer 041
1815 JD Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
Tendinous malletfinger
Exclusion criteria
Fractures, mallet thumb and age < 18 year
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 | NL26264.094.09 |