|- candidate number||3486|
|- NTR Number||NTR1350|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jun-2008|
|- Secondary IDs||07-096 Medisch Ethische Toetsingscommissie Zuidwest Holland|
|- Public Title||Minimax study; open reduction and internal fixation with volar fixed-angle plating vs percutaneous reduction and external fixation for displaced intra-articular fractures of the distal radius in the eldery|
|- Scientific Title||A prospective, randomised multicenter controlled trial on the treatment of displaced intra-articular distal radius fractures in the eldery; open reduction and internal fixation with volair fixed-angle plating versus percutaneous reduction and external fixation|
|- hypothesis||ORIF with volar fixed-angle plates and external fixation have a similar outcome as measured with the DASH score (and the Mayor Wrist Score).|
|- Healt Condition(s) or Problem(s) studied||Elderly patients, Fracture , External fixation , Internal fixation, Displaced intra-articular distal radius fractures|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2008|
|- planned closingdate||1-mrt-2011|
|- Target number of participants||148|
|- Interventions||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.
|- 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
|- Timepoints||Post-operative controll-moments: |
after 1 week, 6 weeks, 3 months, 6 months and one year
|- Trial web site||http://www.cruamc.nl/Minimax|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD J. Keizer|
|- CONTACT for SCIENTIFIC QUERIES||MD J. Keizer|
|- Sponsor/Initiator ||Medical Center Haaglanden, Department of Surgery, Medical Center Haaglanden, Medical Ethical Committee Zuid-West Holland (METC)|
(Source(s) of Monetary or Material Support)
|Haaglanden Medical Center, The Hague|
|- Publications||Handoll HHG, Madhok R. Surgical interventions for treating distal radial fractures in adults (Review), The Cochrane Library 2005, Issue 2 |
Jupiter JB, L. H. (1993). The operative treatment of intraarticular fractures of the distal radius. Clin Orthop , 292: 48-61.
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 patiŽnt. J Hand Surg [Am]. 2004; 29; 96-102
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||18-jun-2008 - 15-jan-2012|