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
Bron
Verkorte titel
Aandoening
Displaced intra-articular distal radius fractures in the eldery (gedisloceerde intra-articulare distale radius fracturen bij de oudere patienten)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primairy outcome measures are:<br>
- wrist function (DASH, Mayo Wrist Score)<br>
- patient satisfaction (SF-36)<br>
- pain sensation (VAS).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
ORIF with volar fixed-angle plates and external fixation have a similar outcome as measured with the DASH score (and the Mayor Wrist Score).
Onderzoeksopzet
Post-operative controll-moments:
after 1 week, 6 weeks, 3 months, 6 months and one year
Onderzoeksproduct en/of interventie
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.
Publiek
Lijnbaan 32
J. Keizer
Den Haag 2512 VA
The Netherlands
+31 (0)70 3302000
j.keizer@lumc.nl
Wetenschappelijk
Lijnbaan 32
J. Keizer
Den Haag 2512 VA
The Netherlands
+31 (0)70 3302000
j.keizer@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1302 |
NTR-old | NTR1350 |
Ander register | Medisch Ethische Toetsingscommissie Zuidwest Holland : 07-096 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
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