The evaluate which treatment of mallet fingers is better, the conventional mallet therapy via the hospital or the personalized treatment with intensive follow up via the handencentrum. This will be investigated for mallet fingers caused by an…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
- To investigate which protocol is most effective in the treatment of mallet
finger; the standard protocol or intensive treatment by hand therapists. This
will be investigated for mallet fingers due to an extensor tendon rupture as
well as the mallet fingers due to an avulsion fracture. The primary end-point
will be the degrees of extension of the involved joint, six months after injury.
Secondary outcome
Secondary Objective(s):
- To investigate if there are differences in scores of the Michigan Hand
Outcome Questionnaire - Dutch Language Version (MHOQ-DLV) and the Canadian
Occupational Performance Measure (COPM)
- To investigate if there is a difference in days away from work
- To investigate if there is a difference patient satisfaction
- To give indication about the costs involved
Background summary
The standard treatment of an uncomplicated mallet finger in the Netherlands is
often a Stack splint worn for six weeks. During the initial consultation at the
emergency department patients are informed about their diagnosis and a splint
is fitted and applied. Patients are informed that the splint should be worn for
24 hours a day and should only be removed for skin care of the involved finger.
During removal of the splint, the finger should be placed on a flat surface to
prevent flexion in the distal in DIP joint. During this six week period the
patient can return once or twice to the outpatient clinic if preferred for a
checkup. After six weeks the splint is removed and patients are advised to
slowly start mobilization of the DIP joint.
A potential limitation of this treatment is that patients are, by the limited
check-ups and skin care involved, tempted to remove the splint and flectate the
DIP joint, disturbing the healing of tendon. Another potential limitation is
the mobilization which is not overseen by a professional. This can lead to a
too early or too late mobilization, resulting in an extensor lag or flexion
limitation, respectively, of the DIP joint.
To overcome these limitations patients we started to refer patient to the hand
therapy center. There a custom made splint is applied and check-ups are more
frequent. The splint is only removed by the therapist to prevent potential
problems of splint removal by the patient themselves. After the six weeks
period patient start gradually to mobilize the DIP joint under supervision of
the therapist.
At this moment both type of treatments, six week Stack splint and hand therapy
center, respectively, take place in the Catharina Hospital Eindhoven, The
Netherlands. The received treatment depends on the type of medical specialty by
whom the patient is evaluated on the emergency department. Patients with a
mallet finger are either seen by the department of plastic surgery or the
department of general surgery, this varies per day due to local agreements.
Study objective
The evaluate which treatment of mallet fingers is better, the conventional
mallet therapy via the hospital or the personalized treatment with intensive
follow up via the handencentrum. This will be investigated for mallet fingers
caused by an extensor tendon rupture as well by an avulsion fracture.
Study design
The injury will be investigated whether it is due to an extensor tendon
rupture, or an avulsion fracture. Both injuries will be regarded and treated as
separate groups. These groups will be analysed via the same research protocol.
The study will be a randomized trial comparing the conventional mallet therapy
via the hospital and the personalized treatment with intensive follow up via
the handencentrum. The study will be performed at the Catharina Hospital,
Eindhoven, The Netherlands and the *Handencentrum*, Eindhoven, The Netherlands.
Recruitment will be initiated at the emergency department of the Catharina
Hospital.
Study burden and risks
The extra burden for participants compared to the *normal* treatment is that
they need to fill in multipele questionnaires, need to have an additional
X-rays taken (of the involved finger and the contralateral finger) and
additional out-patient clinic visit is required.
The filing in of the questionnaires and additional out-patient visit will
require time of the participants. The two additional X-rays will give a
radiation dose of <0.01 mSv. The authors are of opinion that this dose is so
small that it is to be neglected.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
All patients who report themselves at the ER of the Catharina hospital with a malletfinger who meet the following criteria:
- Age: between 18 and 65 years
- Participants need to be able to make their own decision
- Injuries that exist no longer then two weeks
Exclusion criteria
- Deformities or disease of the involved DIP joint
- Open injury
- Inability the complete splinting therapy (e.g. the likelihood of compliance is low due to psychiatric disorders or beginning Alzheimer disease)
- Mallet fingers caused by an avulsion fracture of the base of the distal phalanx involving more then one third of the joint
Design
Recruitment
Medical products/devices used
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 | NL35831.060.12 |