Epidemiology of Limb Amputations and Prosthetic Use During COVID-19 Pandemic in the Netherlands.

OBJECTIVE: To evaluate the trends in the incidence of major limb amputations and the prevalence of Dutch prosthetic users at the national level in The Netherlands between 2012 and 2021 (during the COVID-19 pandemic). Local hospitals in The Netherlands reported a doubling of major lower limb amputations during COVID-19, information about a change in the incidence of major upper limb amputations was not reported. We could not confirm this remarkable increase in major lower limb amputations in our institution, nor did we observe a change in the incidence of major upper limb amputations. We hypothesize that the COVID-19 pandemic had no effect on the number of major limb amputations. DESIGN: Observational retrospective study analyzing national open-access databases of health insurance claims. SETTING: The Dutch national opensource database www.opendisdata.nl was used to retrieve the incidence of limb amputations in the period 2012-2021, stratified by the level of amputation and the cause of amputation. The results were verified using the www.gipdatabank.nl databank. This period included 4 intervals of nationwide COVID-19 lockdowns. PARTICIPANTS: 60,848 patients who underwent limb amputations at the upper or lower extremity in the Netherlands from 2012 to 2021 (N=60,848) were included in this study. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Upper- and lower-limb amputation and prosthetic use. RESULTS: Data were retrieved for a total of 60,848 patients in the Netherlands, who underwent 68,180 amputations of the upper and lower extremities at any level from 2012 to 2021, including 22,095 major amputations of the lower extremities. The ongoing trend of stable numbers of major lower-limb amputations from 2012 to 2019 continued in 2020 and 2021. The verification of these data at the level of prosthetic users confirmed that the annual trends were unchanged. CONCLUSION: The reported increased numbers of major lower-limb amputations during the COVID-19 pandemic in the Netherlands could not be confirmed using nationwide epidemiologic data.

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

BACKGROUND: The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events. QUESTIONS/PURPOSES: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture? METHODS: Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death. RESULTS: Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention. CONCLUSION: Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant. LEVEL OF EVIDENCE: Level III, therapeutic study.

Pain Exposure Physical Therapy versus conventional treatment in complex regional pain syndrome type 1-a cost-effectiveness analysis alongside a randomized controlled trial.

OBJECTIVE: To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis. DESIGN: Randomized controlled trial with 9 months follow-up. SETTING: Patients were recruited from hospitals and general practitioners in the region around a university hospital. SUBJECTS: A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected. INTERVENTIONS: Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline. MAIN MEASURES: For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score-Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs. RESULTS: No significant effects were found for QALYs (mean difference = -0.02; 95% confidence interval (CI) -0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy. CONCLUSION: This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial.

BACKGROUND: Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1. METHODS/DESIGN: This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version. DISCUSSION: This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.

Decreasing incidence of complex regional pain syndrome in the Netherlands: a retrospective multicenter study.

Background: Complex regional pain syndrome type I (CRPS) is a symptom-based diagnosis of which the reported incidence varies widely. In daily practice, there appears to be a decrease in incidence of CRPS after a distal radius fracture and in general. Questions/purposes: The aim of this study was to assess the trend in the incidence of CRPS after a distal radius fracture and in general in the Netherlands from 2014 to 2018. Methods: The incidence of CRPS after a distal radius fracture was calculated by dividing the number of confirmed cases of CRPS after distal radius fracture by the total number of patients diagnosed with a distal radius fracture. Medical records of these patients were reviewed. Hospital-based data were used to establish a trend in incidence of CRPS in general. A Dutch national database was used to measure the trend in the incidence of CRPS in the Netherlands by calculating annual incidence rates: the number of new CRPS cases, collected from the national database, divided by the Dutch mid-year population. Results: The incidence of CRPS after distal radius fracture over the whole study period was 0.36%. Hospital data showed an absolute decrease in CRPS cases from 520 in 2014 to 223 in 2018. National data confirmed this with a decrease in annual incidence from 23.2 (95% CI: 22.5-23.9) per 100,000 person years in 2014 to 16.1 (95% CI: 15.5-16.7) per 100,000 person years in 2018. Conclusion: A decreasing trend of CRPS is shown in this study. We hypothesize this to be the result of the changing approach towards CRPS and fracture management, with more focus on prevention and the psychological aspects of disproportionate posttraumatic pain. Level of Evidence: level 3 (retrospective cohort study).

Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial.

BACKGROUND: The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries. AIM: A prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation. METHODS/DESIGN: A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses. DISCUSSION: This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures. TRIAL REGISTRATION: Netherlands National Trial Register NTR2399.

Is radiation superior to indomethacin to prevent heterotopic ossification in acetabular fractures?: a systematic review.

UNLABELLED: Heterotopic ossification is a well-known complication after fixation of an acetabular fracture. Indomethacin and radiation therapy are used as prophylaxis to prevent heterotopic ossification. It is unclear, however, whether either is superior, although this may relate to lack of power in individual studies. To compare the effectiveness of indomethacin with the effectiveness of radiation therapy, we conducted a systematic review in which all published prospective studies were evaluated. We performed a literature search in PubMed, MEDLINE, EMBASE, and the Cochrane Controlled Trial Register. The retrieved studies were analyzed and categorized according to the quality and validity score of Jadad et al. We found five appropriate prospective studies, describing 384 patients. Although the quality of the available studies made a proper meta-analysis inappropriate, the incidence of heterotopic ossification was significantly lower in patients treated with radiation than in patients receiving indomethacin (five of 160 versus 20 of 224, respectively). Until further information is available, we believe the evidence supports radiation therapy as the preferred method for preventing heterotopic ossification after operative treatment of acetabular fractures. LEVEL OF EVIDENCE: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Rib fixation versus non-operative treatment for flail chest and multiple rib fractures after blunt thoracic trauma: a multicenter cohort study.

BACKGROUND: Over the years, a trend has evolved towards operative treatment of flail chest although evidence is limited. Furthermore, little is known about operative treatment for patients with multiple rib fractures without a flail chest. The aim of this study was to compare rib fixation based on a clinical treatment algorithm with nonoperative treatment for both patients with a flail chest or multiple rib fractures. METHODS: All patients with ≥ 3 rib fractures admitted to one of the two contributing hospitals between January 2014 and January 2017 were retrospectively included in this multicenter cohort study. One hospital treated all patients nonoperatively and the other hospital treated patients with rib fixation according to a clinical treatment algorithm. Primary outcome measures were intensive care length of stay and hospital length of stay for patients with a flail chest and patients with multiple rib fractures, respectively. To control for potential confounding, propensity score matching was applied. RESULTS: A total of 332 patients were treated according to protocol and available for analysis. The mean age was 56 (SD 17) years old and 257 (77%) patients were male. The overall mean Injury Severity Score was 23 (SD 11) and the average number of rib fractures was 8 (SD 4). There were 92 patients with a flail chest, 37 (40%) had rib fixation and 55 (60%) had non-operative treatment. There were 240 patients with multiple rib fractures, 28 (12%) had rib fixation and 212 (88%) had non-operative treatment. For both patient groups, after propensity score matching, rib fixation was not associated with intensive care unit length of stay (for flail chest patients) nor with hospital length of stay (for multiple rib fracture patients), nor with the secondary outcome measures. CONCLUSION: No advantage could be demonstrated for operative fixation of rib fractures. Future studies are needed before rib fixation is embedded or abandoned in clinical practice.

Plate Fixation Compared with Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Multicenter Randomized Controlled Trial.

BACKGROUND: The use of operative treatment for clavicular fractures is increasing, despite varying results in previous studies. The aim of this study was to compare plate fixation and nonoperative treatment for displaced midshaft clavicular fractures with respect to nonunion, adverse events, and shoulder function. METHODS: In this multicenter, prospective, randomized controlled trial, patients between 18 and 60 years old with a displaced midshaft clavicular fracture were randomized between nonoperative treatment and open reduction with internal plate fixation. The primary outcome was evidence of nonunion at 1 year. Other outcomes were secondary operations, arm function as measured with the Constant shoulder score and Disabilities of the Arm, Shoulder and Hand (DASH) score, pain, cosmetic results, and general health status. Outcomes were recorded at 6 weeks, 3 months, and 1 year following trauma. RESULTS: One hundred and sixty patients were randomized. The rate of nonunion was significantly higher in the nonoperatively treated group than in the operatively treated group (23.1% compared with 2.4%; p < 0.0001), as was the rate of nonunion for which secondary plate fixation was performed (12.9% compared with 1.2%; p = 0.006). The rate of secondary operations was 27.4% in the operatively treated group (16.7% for elective plate removal) and 17.1% in the nonoperatively treated group (p = 0.18). Nineteen percent of the patients in the operatively treated group had persistent loss of sensation around the scar. No difference was found between the groups with respect to the Constant and DASH scores at all time points. CONCLUSIONS: For patients with a diaphyseal fracture of the clavicle displaced at least 1 shaft width, plate fixation improves the chances that the bone will heal; however, the rate of patients who need a second operation is considerable. In addition, the procedure does not improve shoulder function or general symptoms, and it does not decrease limitations compared with nonoperative treatment in a sling. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Safety of Osseointegrated Implants for Transfemoral Amputees: A Two-Center Prospective Cohort Study.

BACKGROUND: Osseointegrated implants are an alternative for prosthetic attachment for individuals unable to wear a socket following an amputation. The concept of an integrated metal implant communicating with the external environment raises substantial concern about the risk of ascending infection. We report on the safety of press-fit osseointegrated implants currently used in Australia and the Netherlands. METHODS: We prospectively recorded all adverse events in all patients with transfemoral amputation who were managed with an osseointegration implant system between 2009 and 2013 at two centers. The procedure was performed in two stages. A customized porous-coated implant was placed in the first stage, and a stoma was created in the second. Adverse events were categorized according to type (infection or "other") and severity. Infections were classified according to four grades of severity based on clinical and radiographic findings: (1) low-grade soft-tissue infection, (2) high-grade soft-tissue infection, (3) bone infection, and (4) septic implant failure. RESULTS: Eighty-six patients (ninety-one implants), twenty-five to eighty-one years of age, were included in the study and followed for a median of thirty-four months (range, twenty-four to seventy-one months). Thirty-one patients had an uneventful course with no complications; twenty-nine developed infection (all grade 1 or 2); and twenty-six did not develop infection but had one or more other complications requiring intervention, including stoma hypergranulation (seventeen patients), soft-tissue redundancy (fourteen), proximal femoral fracture (three), inadequate osseointegration leading to implant replacement (one), implant breakage (two), and breakage of the pin used as a fail-safe mechanism (twenty-five). CONCLUSIONS: Mild infection and irritation of the soft tissue in the skin-penetration area are common in transfemoral amputees who have an osseointegrated implant. These complications were successfully managed with simple measures. Severe infections resulting in septic implant loosening are rare. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

[Complex regional pain syndrome type 1: negating the myth]. / Complex regionaal pijnsyndroom type 1: de mythe ontkracht.

Complex regional pain syndrome type 1 (CRPS-1) was identified in the Netherlands more than 30 years ago, but since then the arguments supporting this diagnosis have become weaker. Incidence has decreased, it is often not possible to make a definite diagnosis, the pathophysiology remains unclear and treatments are extremely diverse. Since the patient group is so heterogeneous, it is often unclear exactly which patients should be included. Disuse due to immobilization can give an identical clinical picture, including the inflammatory parameters that are seen in CRPS-1. CRPS-1 following injury can be prevented with exercise, and incidence is declining dramatically. Taking these factors into consideration, we support the view that CRPS-1 is not an illness but rather a 'disuse syndrome' as a result of immobilization, or there may be a missed underlying diagnosis.

Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial.

OBJECTIVE: To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. SETTING: The study was conducted at a level 1 trauma centre in the Netherlands. PARTICIPANTS: 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. INTERVENTIONS: Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. MEASUREMENTS: Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score--Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. RESULTS: The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI -1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. CONCLUSIONS: We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. TRIAL REGISTRATION NUMBERS: NCT00817128 and NTR 2090.

Viable osteoblastic potential of cortical reamings from intramedullary nailing.

To analyze the effect of intramedullary reaming on fracture healing, we investigated whether or not cortical reamings contain viable bone cells. There are several tissue components contained in medullary reamings including blood, bone marrow and cortical bone. This study is focused on the cortical reamings, which are produced during reaming of the medullary cavity. They may stimulate fracture healing but it is still unclear if they contain vital bone cells. We tested the hypothesis that these cortical reamings are a source of viable bone cells and compared cell cultures with cultivated cells from iliac crest biopsies. Responses of protein content and ALP activity to vitD stimulation in the cells were considered as properties of viability. Ten in tact living sheep femora were fully reamed and the cortical reamings were cultivated in a standard manner and compared with cultivated cells from ipsi-lateral iliac crest biopsies from the same animals. Cells started to grow from the reamings as well as the iliac crest within 2-5 days, and covered the entire culture flask within 9-13 days. Protein content and ALP activity in cells from both reamings and iliac crest were significantly responsive to vitD stimulation. Cortical reamings from intramedullary nailing have osteoblastic potential and contain living bone cells similar to bone cells from the iliac crest. These findings may further explain the superior healing of fractures, treated with reamed nailing.

Are pain-related fears mediators for reducing disability and pain in patients with complex regional pain syndrome type 1? An explorative analysis on pain exposure physical therapy.

OBJECTIVE: To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy. DESIGN: An explorative secondary analysis of a randomised controlled trial. PARTICIPANTS: Fifty-six patients with Complex Regional Pain Syndrome type 1. INTERVENTIONS: The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline. OUTCOME MEASURES: Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up. RESULTS: The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation. CONCLUSION: The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment. TRIAL REGISTRATION: International Clinical Trials Registry NCT00817128.

Reaming debris as a novel source of autologous bone to enhance healing of bone defects.

Reaming debris is formed when bone defects are stabilized with an intramedullary nail, and contains viable osteoblast-like cells and growth factors, and might thus act as a natural osteoinductive scaffold. The advantage of using reaming debris over stem cells or autologous bone for healing bone defects is that no extra surgery is needed to obtain the material. To assess the clinical feasibility of using reaming debris to enhance bone healing, we investigated whether reaming debris enhances the healing rate of a bone defect in sheep tibia, compared to an empty gap. As golden standard the defect was filled with iliac crest bone. Bones treated with iliac crest bone and reaming debris showed larger callus volume, increased bone volume, and decreased cartilage volume in the fracture gap, and increased torsional toughness compared to the empty gap group at 3 weeks postoperative. In addition, bones treated with reaming debris showed increased torsional stiffness at 6 weeks postoperatively compared to the empty defect group, while bending stiffness was marginally increased. These results indicate that reaming debris could serve as an excellent alternative to iliac crest bone for speeding up the healing process in bone defects that are treated with an intramedullary nail.

[The endo-exo prosthesis for patients with a problematic amputation stump]. / Klikprothese (endo-exoprothese) voor patiënten met een problematische amputatiestomp.

Following lower limb amputation, quality of life is highly related to the ability to use a prosthetic limb. The conventional way to attach a prosthetic limb to the body is with a socket. Many patients experience serious discomfort wearing a conventional prosthesis because of pain, instability during walking, pressure sores, bad smell or skin irritation. In addition, sitting is uncomfortable and pelvic and lower back pain due to unstable gait is often seen in these patients. The main disadvantage of the current prosthesis is the attachment of a rigid prosthesis socket to a soft and variable body. The socket must fit tightly for stability during walking but should also be comfortable for sitting. The implantation of an osseointegrated, intramedullary, transcutaneously conducted prosthesis is a new procedure for attaching a limb prosthesis to the human body without the disadvantages of the conventional prosthesis. The intramedullary prosthesis is designed with a rough surface resembling cancellous bone to enable a secure solid integration with the long bone. We treated two patients with this new prosthesis, a 44-year-old man after a transfemoral amputation, and a 32-year-old woman after a lower leg amputation; both amputations were necessary because of trauma. Those two patients are now, more than one year after the operation, showing excellent functional results without infectious complications. We assume that endo-exo prosthesis may be a promising option for selected patients unable to use a conventional prosthesis because of a problematic amputation stump.

Mannitol as salvage treatment for Complex Regional Pain Syndrome Type I.

INTRODUCTION: Complex Regional Pain Syndrome Type I (CRPS I) is a continuation of symptoms and signs due to a pathological exaggerated reaction in an extremity of the human body after an injury or operation. Although the clinical picture of CRPS I in the majority of patients is well known, the underlying pathophysiology remains unclear. In The Netherlands, intravenous mannitol administration used as hydroxyl radical scavenger for patients who do not respond to conservative treatment of CRPS I is advocated but little evidence supports this salvage strategy. In this study the effect of mannitol as salvage medication was evaluated in a well-defined multimodal step-up treatment protocol. PATIENTS AND METHODS: A consecutive group of 68 adult patients with persistent CRPS I was analysed, who underwent a total of 100 mannitol infusions. The effect of treatment was considered per sign and per symptom according to the Veldman et al. criteria for CRPS I. RESULTS: Overall improvement of CRPS I after mannitol treatment was successful in 24% after 1 week, and in 30% after 1 month. Mannitol treatment had some effect in patients with initially warm CRPS I in contrast to patients with cold CRPS I (OR=6.30 with CI [2.37-16.75]). Also patients with CRPS I at the upper extremity had more benefit than patients with CRPS I at the lower extremity (OR=3.26 with CI [1.34-7.93]). Poor results of mannitol treatment were associated with cold CRPS I (p<0.001), chronic CRPS I (p=0.04) and multiple mannitol treatments (p=0.04). CONCLUSION: Mannitol did not significantly contribute to the overall success of treatment in patients with CRPS I. Patients, presenting with acute, warm CRPS I in the upper extremity may have some benefit.

Progressive ossification due to retained surgical sponge after upper leg amputation: a case report.

INTRODUCTION: Numerous cases are described of patients in whom foreign objects were found after surgery. Foreign body granuloma caused by retained surgical sponge, also called gossypiboma, mostly occur in the abdominal cavity but very seldom in limbs. CASE PRESENTATION: A 29-year-old Caucasian man presented with asymmetrical walking pattern and progressive pain in his leg, which was severely injured and amputated seven years before. A firm swelling of soft tissue with calcifications was localized in the stump. Roentgenogram and MRI showed a retained surgical sponge with calcifications. Open surgery was performed and a well-encapsulated, brownish soft-tissue tumour containing serous fluid was found in which the remnants of a surgical sponge of 40 x 40 centimeters was identified and removed. Infectious complications characterized the postoperative course for which multiple surgical procedures were needed to create a definitive healing of the stump. CONCLUSION: A surgical sponge left behind in an amputated leg may lead to fibroma, destruction, osteolysis and calcification. In our case the gauze lead to mild dysfunction of the prosthetic leg, asymmetrical walking pattern, phantom pain and calcification and osteolysis on roentgenogram.