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The total score was calculated and varied between zero and At least ten questions had to be answered for the form to be valid [ 13 , 14 ]. In addition, healthcare costs for various treatments, such as outpatient or surgery visits, rehabilitation, and treatment by nurses, were estimated. Lengths of hospital stay and sick leave were calculated among the subjects who were admitted to the hospital and those still in the labour market, respectively.
Subjects who were operated on primarily for another main disorder of the hand were excluded. Subjects were divided according to whether they underwent an open surgical procedure or a percutaneous procedure. Subjects with procedures, such as arthrodesis or amputations, were excluded. Additional data, such as age, gender, body mass index BMI , disease severity i. Three subjects were excluded due to insufficient information obtainable from the records. When available, the preoperative QuickDASH, as well as the above information, were also collected from the records of those subjects who had been excluded because of the lack of or an invalid postoperative QuickDASH.
Thus, allowed comparison between excluded and included patients. The following revised model of the Tubiana staging system was used:. Values are presented as median [IQR; 25 — 75 percentiles]. The chi-square and the Mann-Whitney tests were used to detect any significant differences between groups. The present project, and those with similar design, is not covered by the law The study has been done in compliance with the Helsinki Declaration http: In total different procedures were performed.
Thus, three subjects were not available for analyses, resulting in a selected group of patients and procedures. Thus, the group of subjects that could tentatively be studied comprised procedures i. Most of the subjects had an open surgical procedure; i. Among the open procedures i. The median improvement in Tubiana score was 3 [ 2 - 4 ] stages.
QuickDASH scores decreased after surgery among subjects in the whole population. There were no significant differences between the data from the excluded and the included subjects. The data of the excluded subjects are not included in other parts of the Results below or in any of the Tables. Smokers were younger than non-smokers and the preoperative extension deficit in the worst affected finger was more severe in smokers than in non-smokers.
However, the preoperative extension deficit, as evaluated by Tubiana scoring, did not differ between the two groups. Postoperatively, there were no significant differences in any outcome variables between smokers and non-smokers. The subjects with diabetes were younger than the patients without diabetes, while BMI did not differ significantly.
As expected, the presence of treated hypertension differed significantly between patients with and without diabetes being more common in subjects with diabetes, and a similar pattern was also observed for treatment with statins. There were no significant differences between subjects with and without diabetes in pre- or post-operative severity of flexion contracture or in improvement after surgery expressed in degrees. Furthermore, the Tubiana stages did not differ between the two groups.
In addition, the data concerning characteristics of the subjects are consistent with a previous study with a larger population of subjects [ 18 ], indicating that our population is relevant in European context.
Furthermore, subjects with diabetes were also younger than those without diabetes, but again the outcomes did not differ. Specialists in hand surgery operated ten minutes faster than residents, but outcomes after open surgery were no different, irrespective of the presence of the risk factors smoking or diabetes among the subjects. It may be caused by factors related to the subjects, i. The smokers had a higher preoperative QuickDASH score, although they were younger than the non-smokers. Nevertheless, there were no significant differences in postoperative QuickDASH score or in improvement of QuickDASH score between smokers and non-smokers, indicating that open surgical treatment can be performed later without jeopardizing the outcome, the postoperative Tubiana score or the extension deficit.
In addition, the present smokers did not have a higher percentage of complications, such as necrosis of skin flaps including delayed healing or infections, but one cannot entirely exclude the possibility that the limited number of subjects in the present study may have precluded the detection of any difference in complications. Therefore, the present findings should be interpreted with some caution and the results should be confirmed in larger populations from national registries. Our treated subjects with diabetes were younger indicating, in accordance with other studies [ 1 ], that the disease occurs earlier in subjects with diabetes.
However, there were no differences in any outcome variables between the subjects with and without diabetes, except that subjects with diabetes were younger. Subjects with diabetes may have a higher incidence of postoperative complications [ 1 ], but this is in contrast to our study results. The length of stay at the ward in subjects who were admitted differed from that for northern Europe in general i. A reduction in the number of unnecessary days on the ward may reduce costs for the healthcare system since admission to a ward in connection with a surgical treatment is expensive and resource intensive, which is an important point in view of a lower financial support to hospitals and an increased population globally.
However, admission to a ward may be required if the procedure is a reoperation with a risk of surgical complications, or the subject has a complicated health condition e. Interestingly, smokers had a shorter stay at the ward and thus potentially lower costs. Finally, some of the treated subjects were still on the labour market and needed sick leave after the surgery, resulting in a loss of production; thus, a further cost for the society.
One should also consider the costs for collagenase treatment; i. It has been estimated that the average patient needs to treat 1.
However, the complexity of the disease, with various severity of the disease, makes it difficult to judge the exact costs for treatment in a simple way [ 20 ], since the recurrence after collagenase treatment and percutaneous needle fasciotomy may be faster than after surgery, which should be taken into account.
Surgery may also require admission to a ward in some patients, where the other two procedures can be performed as outpatient procedures. These results are interesting from a cost point of view as well as logistically. The data concerning the number of treatment sessions by nurses, physiotherapists and occupational therapists may possibly be an underestimation, since the data recorded in the medical charts may be incomplete and such categories of staff may have treated some subjects outside the department.
A similar limitation, related to an underestimation of the costs, is that we had no information about how many outpatient visits the subjects made to their GP before referral, but approximately half of the subjects were referred from a GP. The rest of the subjects were or had been treated for another hand condition at the department. However, these are probably low in comparison with the treatment costs; i. Another limitation is the time period i.
Had the time period for data collection been longer a more accurate evaluation of costs could have been made. However, forms with declarations of health together with QuickDASH data were only available during the selected time period. We would therefore suggest that trials utilize goniometer based, blinded, and independent measurements of the active and passive extension deficit. Goniometer measured extension deficits have a high degree of inter-rater reliability intraclass co-efficient 0. The degree of extension deficit may be quantified in degrees of motion or with the use of grading systems such as described by Tubiana [ 15 ].
However, in using grading systems there is inevitably loss of data when converting from an exact measure to a limited range, and therefore a reduction in sensitivity. For example, a pre-operative PIPJ contracture of 40 degrees and post-operative of 0 degrees, are both Tubiana Grade 1 defined as a total extensor deficit of 0 to 45 degrees. Furthermore, grading systems may create artificial statistical boundaries eg, Grade 1 vs Grade 2. The use of statistical methods on the raw data in degrees is a more valid method of analysis.
More exact definitions include those used by Van Rijssen et al. These differences in measurements of endpoints serves to highlight the difficulty in making valid comparisons of outcomes in single cohort studies. Furthermore, as PIPJ or MCPJ disease may have differing clinical courses and implications, measurements should be applied in a joint-specific manner rather than on total range of motion. The definitions developed and used in the CORD trials are the most exact in the literature, are joint-specific, less prone to bias, and are advocated for use in future studies. The second form of outcome measure used in many studies is the functional assessment scale, such as the DASH score.
First, studies suggest that they do not necessarily correlate with disease severity, and second, their relevance to patient reported outcomes is questionable.
This concept attempts to correlate objective measurements such as contracture angle, with subjective measures of patient outcomes, such as perceived benefit or satisfaction. It therefore gives the patient tangible answers to previously abstract concepts such as contracture angle. Only 1 surgical RCT was noted in this time period. As the CORD I study was published in , it precedes the inclusion date of the articles included for this review.
However, in brief, the CORD I study was a randomized, placebo controlled, multicenter trial in the United States involving patients. The treatment arm was collagenase clostridium hystolyticum 0. The primary endpoint was a reduction in contracture to 0—5 degrees from normal.
Serious adverse events occurred in 3 cases - 2 tendon ruptures and 1 chronic regional pain syndrome. The primary endpoint was achieved on average at day Recently, there has been a drive to increase the level of evidence in surgical journals, without adequately addressing the quality of trials. Future directions in clinical research may need to address the role of collagenase further. Although the efficacy of collagenase has been demonstrated against placebo, and FDA approval granted, this does not equate to superiority over traditional surgical techniques. More data on longevity, recurrence rates, comparison to needle fasciotomy, and limited fasciectomy, is required before endorsing this as a more effective and safer alternative to surgery.
Our approach is broadly in line with the guidelines established by the British Society for Surgery of the Hand [ 28 ]. Notably, these are in conflict with those established by other clinical bodies such as the National Institute for Clinical Excellence NICE [ 29 ], particularly concerning treatments that lack high levels and quality of evidence, such as radiotherapy. This serves to highlight the importance of transparent assessment of treatments against established quality criteria such as the Detsky scale, and standardization of outcome measures, in order to minimize personal bias in the interpretation of evidence.
No potential conflicts of interest relevant to this article were reported. National Center for Biotechnology Information , U. Curr Rev Musculoskelet Med. Published online Dec Steven Lo and Mark Pickford. This article has been cited by other articles in PMC. Results Level I and II evidence 7 articles labeled as randomized controlled trials were retrieved - 4 of these were original RCTs whilst 3 were secondary analyses of previously published RCTs.
Open in a separate window. Level III evidence Two comparative studies were retrieved, 1 concerning the economic analysis of techniques not discussed [ 7 ] , and the other concerning the use of cellulose in segmental fasciectomy [ 8 ]. Level IV evidence Eleven therapeutic single cohort studies were identified, but are not discussed further in this article. Functional outcome measurements analyses The second form of outcome measure used in many studies is the functional assessment scale, such as the DASH score.
This study was a secondary analysis of a RCT, which demonstrated that the DASH score has none, or a very weak association with flexion contractures of the digits. The correlation between Total Range of Motion using active extension deficit and the DASH score was studied in patients undergoing limited or dermo-fasciectomy. Other trials on the DASH score have also demonstrated a weak or absent correlation with flexion contracture [ 19 , 20 ].
Also the DASH score emphasizes tripod grip rather than ulnar sided grip, with tasks such as writing and turning a key. Alternative functional outcome scales should be considered. This study had 2 main aims. This study was performed by regression modeling of patient reported outcomes with objective measures such as the contracture angle. This equates to a This study suggests that a Needle aponeurotomy vs limited fasciectomy Study: Van Rijssen et al.
This was a prospective randomized controlled trial of needle fasciotomy vs limited fasciectomy in patients with a 5-year follow-up.
Patients with a total passive extension deficit of greater than 30 degrees in a single ray were included. The Abe diathesis score was assessed for each patient pre-operatively. They also analyzed post-operative success rates using the endpoints defined by the CORD 1 study correction of individual joint contracture to with 0 degrees to 5 degrees of normal. Satisfaction scores were also assessed using their own scoring system. The Abe diathesis score did not correlate with an increased risk of recurrence with either technique.
Interestingly, older age groups were also associated with a decreased risk of recurrence with both techniques. This randomized controlled trial was well designed with a long follow-up period. However, blinding of measurements is not clear from this study, with surgical scars possibly making it obvious to the assessor what form of treatment has been performed. Main methodological limitations included lack of blinding, description of unenrolled patients, and power analysis.
The level of evidence and quality of this trial supersedes that of other previous single cohort studies in the literature, and provides the best evidence that limited fasciectomy is superior to needle fasciotomy, when recurrence and initial success of contracure release are used as clinical endpoints. However, these are not the only considerations when evaluating treatment options, and complication rates and time off work need to be factored into the evaluation.
This study also suggests that needle fasciotomy may have a more significant role in the older patient group who may have a lower long-term recurrence rate.
Disclosure No potential conflicts of interest relevant to this article were reported. Segmental fasciectomy was performed and a commercially available cellulose implant was interposed in the residual space. Scope of articles was limited to therapeutic clinical studies, and excluded epidemiological, basic science, and economic analyses. RESULTS Twenty-one hands in 19 patients 13 males, 6 females who underwent surgery and had adequate follow-up were retrospectively evaluated. Dupuytren diathesis and genetic risk. Assessing the quality of reports of randomized clinical trials: Another limitation is the time period i.
Trials on adjuncts to surgery 3 trials of level I-III evidence were included from , on the adjunctive use of steroid injection, night-time splinting, and cellulose implants. Needle fasciotomy with or without steroids Study: No placebo injections were used in the control group, and therefore this study was not adequately controlled or blinded. Change in total active extension deficit TAED compared with pre-operative baseline was used as the primary outcome measure.
No complications were reported in either group. Longer follow-up would be required to confirm this as a valid adjunct to surgery. Furthermore, no blinding was performed, with all surgery, injections and measurements performed by a single operator, thereby providing a source of potential bias. Main methodological limitations included lack of blinding of assessment, control group, description of unenrolled patients, and power analysis.
Dupuytren's disease: a concept of surgical treatment. Peter Brenner, Ghazi M. Rayan. New York: Springer-Verlag Wien, , pages, $ Robert M. Dupuytren's Disease. A Concept of Surgical Treatment. Authors: Brenner, Peter Dupuytren's disease—a historical overview. Brenner, Peter, MD PhD (et al.).
There are some methodological concerns regarding these outcomes and further studies would be suggested before recommending steroids as an adjunctive treatment. Postoperative nocturnal splinting after limited or dermo-fasciectomy Study: Few methodological limitations included lack of blinding, and no description of unenrolled patients. The efficacy of routine post-operative night splinting has not been demonstrated. Night splinting therefore does not need to be performed on a routine basis post-operatively, with early recurrent contractures treated on a reactive basis with splinting.
Cellulose implants in segmental fasciectomy Study: Single center, prospective case control study involving 29 patients, 15 received a cellulose implant, and 14 without. Segmental fasciectomy was performed and a commercially available cellulose implant was interposed in the residual space. All patients were fully corrected after surgery with full extension. This study uses a pseudo case-control technique, without true matching of patients. Blinding of assessment is not clearly explained in this paper.
A randomized trial would be suggested to confirm these findings. Trials of non-surgical interventions 2 trials of non-surgical interventions were initially rated as Level I—III, with 1 later downgraded to level IV.