Surgery versus conservative treatment in patients with type A distal radius fractures, a randomized controlled trial

BMC Musculoskeletal Disorders (Impact Factor: 1.72). 03/2014; 15(1):90. DOI: 10.1186/1471-2474-15-90
Source: PubMed


Fractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures, especially extra-articular fractures, are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. Initial treatment according to Dutch guidelines consists of closed reduction and plaster immobilisation. If fracture redisplacement occurs, surgical treatment is recommended. Recently, the use of volar locking plates has become more popular. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation in patients with displaced extra-articular distal radius fractures.
This single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture, which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Secondary outcomes comprise the Patient-Rated Wrist Evaluation score (PRWE), quality of life, pain, range of motion, radiological parameters, complications and cross-overs. Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included and this trial will require an estimated time of two years to complete and will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network.Dicussion: Ideally, patients would be randomised before any kind of treatment has been commenced. However, we deem it not patient-friendly to approach possible participants before adequate reduction has been obtained.Trial registration: This study is registered at the Netherlands Trial Register (NTR3113) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on 01-10-2012.

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Available from: Monique Walenkamp, Oct 21, 2014
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    • "The soon return to work is also an interest shared by health insurers and ultimately by the general public as well. It has become increasingly clear that priority should be given not only to clinical outcomes but also to the patient’s perception of HRQOL [10,16,25]. HRQOL is not measured directly but rather indirectly with measurement scales derived from questionnaires. "
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    ABSTRACT: Background This study aimed to present functional results and patient’s health related quality of life (HRQOL) data ten years after volar locked plate fixation (VPF) of unstable intra-articular distal radial fractures (DRF). Methods Thirty-nine patients with a mean age of sixty-one years were operatively treated with VPF after intra-articular distal radial fractures. They were evaluated two, six, and ten years postoperatively according to the Gartland and Werley score. For subjective evaluation the Short Form 36 (SF-36) and the Disability of Arm, Shoulder and Hand (DASH) questionnaires were adopted. Results Overall, wrist function did not differ significantly two, six and ten years after the operation. Over 90% patients achieved “good” or “excellent” results ten years after surgery according to the Gartland and Werley score. Ten years postoperatively the results of the SF 36 did not differ significantly from the two- and six-year follow-up. Overall findings from the SF-36 did not differ significantly from the data of Austrian and American norm populations. Only in the subscale of mental health (MH) the ten-year follow-up did show significantly poorer results (p = 0.045) compared to the Austrian norm population. The median DASH scores did not show significant differences during the ten-year follow-up period. Conclusion The ten-year results of this single-center study suggest that operative treatment of intra-articular DRF with volar locked plates is a useful and satisfactory therapy option, both in terms of function and HRQOL.
    BMC Musculoskeletal Disorders 07/2014; 15(1):250. DOI:10.1186/1471-2474-15-250 · 1.72 Impact Factor
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    ABSTRACT: Eine 74-jährige Patientin zog sich im Rahmen eines Sturzes eine distale Radiusfraktur mit Abriss des Processus styloideus ulnae zu. Nach initialer Reposition in Bruchspaltanästhesie erfolgte eine konservative Therapie im gespaltenen Unterarmgips. Trotz zunehmender Dislokation im Rahmen der radiologischen Kontrollen wurde die Stellung von den behandelnden Ärzten als achsgerecht bezeichnet, weswegen eine therapeutische Konsequenz im Sinne eines Verfahrenswechsels auf ein operatives Vorgehen ausblieb. So zeigte sich 9 Monate nach dem Unfall trotz einer 7-monatigen krankengymnastischen Beübung eine Bewegungseinschränkung im rechten Handgelenk mit lokaler Weichteilschwellung. Im anschließenden Rechtsstreit warf die Patientin den behandelnden Ärzten eine falsche Behandlung ihrer distalen Radiusfraktur mit daraus resultierenden starken Schmerzen sowie einer Fehlstellung im rechten Handgelenk vor, welche sie im Alltag erheblich behindern. Das Gutachten der Schlichtungsstelle stellte eine fehlerhafte Behandlung im Sinne einer objektiv nicht nachzuvollziehenden Indikationsstellung fest. Bereits bei der ersten Vorstellung der Patientin hätte bei Vorliegen mehrerer radiologischer Instabilitätskriterien eine primäre Operationsindikation bestanden. Spätestens aber hätte die zunehmende Dislokation im Rahmen der radiologischen Kontrollen Anlass für die Empfehlung einer operativen Therapie sein müssen. Die Schlichtungsstelle führte des Weiteren aus, dass es bei der Patientin fehlerbedingt zu einer erheblichen Fehlstellung im rechten Handgelenk gekommen sei, welche zu einer Kraftminderung und im weiteren Verlauf zu umformenden Veränderungen im Handgelenk führen wird. Rechtliche Aspekte des Falls werden diskutiert.
    Der Unfallchirurg 10/2014; 117(11). DOI:10.1007/s00113-014-2658-4 · 0.65 Impact Factor
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    ABSTRACT: The Patient-rated Wrist Evaluation (PRWE) is a commonly used instrument in upper extremity surgery and in research. However, to recognize a treatment effect expressed as a change in PRWE, it is important to be aware of the minimum clinically important difference (MCID) and the minimum detectable change (MDC). The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change, while the MDC is defined as the smallest amount of change that can be detected by an outcome measure. A numerical change in score that is less than the MCID, even when statistically significant, does not represent a true clinically relevant change. To our knowledge, the MCID and MDC of the PRWE have not been determined in patients with distal radius fractures. We asked: (1) What is the MCID of the PRWE score for patients with distal radius fractures? (2) What is the MDC of the PRWE? Our prospective cohort study included 102 patients with a distal radius fracture and a median age of 59 years (interquartile range [IQR], 48-66 years). All patients completed the PRWE questionnaire during each of two separate visits. At the second visit, patients were asked to indicate the degree of clinical change they appreciated since the previous visit. Accordingly, patients were categorized in two groups: (1) minimally improved or (2) no change. The groups were used to anchor the changes observed in the PRWE score to patients' perspectives of what was clinically important. We determined the MCID using an anchor-based receiver operator characteristic method. In this context, the change in the PRWE score was considered a diagnostic test, and the anchor (minimally improved or no change as noted by the patients from visit to visit) was the gold standard. The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID. In our study, the MCID of the PRWE was 11.5 points. The area under the curve was 0.54 (95% CI, 0.37-0.70) for the pain subscale and 0.71 (95% CI, 0.57-0.85) for the function subscale. We determined the MDC to be 11.0 points. We determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID. We recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinically relevant difference when evaluating the effects of treatments and when performing sample-size calculations on studies of distal radius fractures.
    Clinical Orthopaedics and Related Research 06/2015; 40(9). DOI:10.1007/s11999-015-4376-9 · 2.77 Impact Factor