Project description:ObjectivesTo determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.DesignRandomised controlled feasibility trial.SettingTwo vascular Centres in South Wales, UK.Participants50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.InterventionsThe treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.Primary and secondary outcome measuresThe primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.ResultsSeventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.ConclusionsRecruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.Trial registration numberISRCTN: 85 710 690. EudraCT: 2016-003544-37.

Project description:PurposeThe purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures.DesignThe design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention.ParticipantsPatients aged 18 years or over who were referred from primary to secondary care for treatment of a hand with Dupuytren's contractures of one or more fingers of more than 30° at the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints and well-defined cord(s). Patients were excluded if they had undergone previous Dupuytren's contracture surgery on the same hand.MethodsPotential participants were screened for eligibility. Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment. Data on recruitment rates, completion of follow-up, and procedure costs were collected. Four patient reported outcome measures (PROMs) and objective outcome measures were collected before intervention and 6 weeks and 6 months afterwards.ResultsOne hundred and fifty-three of 267 (57%) primary-care referrals for Dupuytren's contractures met the eligibility criteria for the study. Seventy-one of the 153 (46%) agreed to participate and were randomly allocated to treatment with needle fasciotomy or limited fasciectomy. Sixty-seven of these underwent their allocated treatment, two were crossovers from limited fasciectomy to needle fasciotomy, and two (both allocated limited fasciectomy) received no treatment. Fifty-nine participants (85%) completed 6-month follow-up PROMs. Participants felt the MYMOP, PEM and URAM PROMs allowed them to better describe how their treatment affected their hand function than the DASH PROM. The estimated costs of limited fasciectomy (in an operating theatre) and needle fasciotomy (in a clinic room) were £777 and £111 respectively.ConclusionA large RCT comparing treatment of Dupuytren's contractures by needle fasciotomy and limited fasciectomy is feasible. Data from this study will help determine the number of sites and duration of recruitment required to complete an adequately powered RCT and will assist the selection of PROMs in future studies on the treatment of Dupuytren's contractures. (Level 1 feasibility study).Trial registrationTrial registered with ISRCTN (registration number: ISRCTN11164292), date assigned - 28/08/2015.

Project description:BackgroundAn understudied area of proximal first metatarsal osteotomies is the effect on articular contact properties following the surgeries. Potential long-term risks include altered joint mechanics and possible arthritic progression. A biomechanical comparison of articular characteristics of the proximal opening wedge and Ludloff osteotomies was performed in this study. It was hypothesized that the proximal opening wedge osteotomy (POWO) would lead to greater alterations in articular contact properties along the first ray.MethodsSeven paired fresh-frozen below-knee cadaveric limbs with hallux valgus were selected. Specimens in each pair were tested in the intact state and then randomized to receive either a Ludloff or POWO. A 4-mm opening wedge osteotomy was used in all cases. Loading of the flexor hallucis longus was to 100 N using an instrumented tensioner. A 28-N load was added at the distal phalanx to simulate the ground reaction force. First metatarsophalangeal (MTP) and tarsometatarsal (TMT) articular properties were recorded simultaneously using 2 pressure sensors. For each state, a pressure map was generated and contact area, peak pressure, and center of pressure were calculated. Wilcoxon signed-rank test was used to assess statistical significance.ResultsAverage peak pressure was noted to be elevated at the MTP (4.6 vs 6.9 mPa, P = .04) and TMT (3.3 mPa vs 5.1 mPa, P = .30) joints when comparing the Ludloff and the POWO, respectively. Contact area was also noted to be lower in the POWO relative to the Ludloff for the MTP (86.6 vs 69.1 mm2, P = .30) but not the TMT joints (89.1 vs 88.5 mm2, P = .97). There was a slight plantar-lateral and dorsomedial shift in pressure at the MTP and TMT articulations, respectively, of the POWO relative to the Ludloff. A trend toward decreased contact force within the TMT joint was noted following opening wedge osteotomy relative to the intact state (103.8 vs 113.9 N, P = .31), while forces were elevated at the MTP joint (104.3 vs 96.0 N, P = .63), although not statistically significant. Smaller increases in TMT and MTP joint forces were noted following the Ludloff when compared to the intact state (95.6 vs 93.3 N at TMT and 109.2 vs 103.2 N at MTP).ConclusionPOWO can potentially change articular contact characteristics along the TMT and MTP articulations of the first ray. This could possibly lead to altered loading patterns and possible long-term damage vs other osteotomies.Clinical relevanceWhile it is unlikely that the changes observed with the sizes of the osteotomy commonly used would lead to long-term significant clinical consequences, further study with larger group sizes would be beneficial.

Project description:Women presenting with reduced fetal movements (RFM) in the third trimester are at increased risk of stillbirth or fetal growth restriction. These outcomes after RFM are related to smaller fetal size on ultrasound scan, oligohydramnios and lower human placental lactogen (hPL) in maternal serum. We performed this study to address whether a randomised controlled trial (RCT) of the management of RFM was feasible with regard to: i) maternal recruitment and retention ii) patient acceptability, iii) adherence to protocol. Additionally, we aimed to confirm the prevalence of poor perinatal outcomes defined as: stillbirth, birthweight <10th centile, umbilical arterial pH <7.1 or unexpected admission to the neonatal intensive care unit.Women with RFM ?36 weeks gestation were invited to participate in a RCT comparing standard management (ultrasound scan if indicated, induction of labour (IOL) based on consultant decision) with intensive management (ultrasound scan, maternal serum hPL, IOL if either result was abnormal). Anxiety was assessed by state-trait anxiety index (STAI) before and after investigations for RFM. Rates of protocol compliance and IOL for RFM were calculated. Participant views were assessed by questionnaires.137 women were approached, 120 (88%) participated, 60 in each group, 2 women in the standard group did not complete the study. 20% of participants had a poor perinatal outcome. All women in the intensive group had ultrasound assessment of fetal size and liquor volume vs. 97% in the standard group. 50% of the intensive group had IOL for abnormal scan or low hPL after RFM vs. 26% of controls (p?<?0.01). STAI reduced for all women after investigations, but this reduction was greater in the standard group (p?=?0.02). Participants had positive views about their involvement in the study.An RCT of management of RFM is feasible with a low rate of attrition. Investigations decrease maternal anxiety. Participants in the intensive group were more likely to have IOL for RFM. Further work is required to determine the likely level of intervention in the standard care arm in multiple centres, to develop additional placental biomarkers and to confirm that the composite outcome is valid.ISRCTN07944306.

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