ORIF with volar fixed-angle plates and external fixation have a similar outcome as measured with the DASH score (and the Mayor Wrist Score).
ID
Source
Brief title
Health condition
Displaced intra-articular distal radius fractures in the eldery (gedisloceerde intra-articulare distale radius fracturen bij de oudere patienten)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primairy outcome measures are:
- wrist function (DASH, Mayo Wrist Score)
- patient satisfaction (SF-36)
- pain sensation (VAS).
Secondary outcome
Secondary outcomes are:
- radiographic parameters
- the number of complications
Background summary
Fractures of the distal radius are a common clinical problem, frequently seen on the emergency department. Almost 60 % of all distal radius fractures represents intra-articular fractures. Because displaced intra-articular fractures of the distal radius are considered to be unstable, operative treatment is necessary for acceptable functional outcome after union. There is no consensus of best operative treatment of these fracture types. The traditional approach to treating intra-articular distal radius fractures has been external fixation.
In recent years, the use of volar, locked plates has gained popularity as a treatment option in the management of these fractures. This study aims to demonstrate a clinically significant difference using the Disability of Arm, Shoulder and Hand (DASH) score after one year. Open reduction and internal fixation using volar fixed-angle locking plates and percutaneous reduction and fixation with external fixation will be compared in an adequately powered, multicenter randomized controlled trial with 2 treatment arms. Clinical outcome will be measured using the DASH-score, the Mayo Wrist score, standard physical exam and radiographic criteria after 6 weeks, 3 months, six months and one year.
Study objective
ORIF with volar fixed-angle plates and external fixation have a similar outcome as measured with the DASH score (and the Mayor Wrist Score).
Study design
Post-operative controll-moments:
after 1 week, 6 weeks, 3 months, 6 months and one year
Intervention
This study will randomise between:
1. Open reduction and internal fixation via a volar approach using volar fixed-angle locking plates and
2. Closed reduction, percutaneous pinnen and fixation, and external fixation with additional adjuncts.
Lijnbaan 32
J. Keizer
Den Haag 2512 VA
The Netherlands
+31 (0)70 3302000
j.keizer@lumc.nl
Lijnbaan 32
J. Keizer
Den Haag 2512 VA
The Netherlands
+31 (0)70 3302000
j.keizer@lumc.nl
Inclusion criteria
1. All patients with a displaced intra-articular fracture of the distal radius.
2. More than 50 years old.
3. Compos Mentis.
4. Living in the Netherlands.
5. Informed Consent.
6. Closed fractures or open fractures Gustillo 1-2.
Exclusion criteria
1. a fracture older than 14 days.
2. Grade III open fractures.
3. ASA IV-V.
4. Participation in other studys.
5. Severe Wrist artrose or limited wrist motion before fracture.
6. Fractures on both sides (left and right).
7. Chronic substance abusus.
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 |
---|---|
NTR-new | NL1302 |
NTR-old | NTR1350 |
Other | Medisch Ethische Toetsingscommissie Zuidwest Holland : 07-096 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
Jupiter JB, L. H. (1993). The operative treatment of intraarticular fractures of the distal radius. Clin Orthop , 292: 48-61.<br><br>
Nana AD, Joshi A, Lichtman DM. Plating of the distal radius.
J Am Acad Orthop Surg. 2005; 13; 159-171
Orbay JL, Fernandez DL. Volar fixed-angle plate fixation for unstable distal radius fractures
in the elderly patiƫnt. J Hand Surg [Am]. 2004; 29; 96-102