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The effect of a fibrin sealant on knee function after total knee replacement surgery. Results from the FIRST trial. A multicenter randomized controlled trial.

ABSTRACT: BACKGROUND:Total knee replacement (TKR) is increasingly performed in short term hospital stay, making same day mobilization an important issue is after surgery. This implies little joint effusion by reducing intra-articular blood loss, which will enhance knee range of motion. The application of a topical fibrin sealant on the intraoperative bare bone and synovial tissue may contribute to better early full mobilization and thus improved functional outcomes. Since ambulation with a fully extended knee is less strenuous, we hypothesized that patients who received fibrin sealant would demonstrate improved early knee extension after six weeks compared to patients who received standard care. METHODS:A multicenter randomized controlled trial in a consecutive series of osteoarthritis patients scheduled for TKR surgery. Participants were randomized to receive fibrin sealant or not before closing the knee joint capsule. Primary outcome was change in knee extension angle(°) at short term (2 weeks) follow-up (cExt). Secondary outcomes were 6-week extension angle, knee flexion angle, hemoglobin loss, blood transfusion rates, complication rates, the Knee Society Score, and the KOOS and EQ5D questionnaires. RESULTS:When data on primary outcome became available from 250 patients, an interim analysis was performed by an independent Data Safety Monitoring Board for safety and effectivity assessment. This analysis showed that sufficient patients were included to detect a cExt of 10° between both groups. Inclusion was stopped however, all in the meantime included patients were treated according to their randomization. A total of 466 were available for analysis. Both groups were comparable in terms of baseline characteristics. The estimated mean cExt difference was 0.2° (95%CI -0.5 to 0.9). No differences in secondary outcomes were found. CONCLUSIONS:No beneficial effects or side effects were found of a topically applied fibrin sealant during TKR surgery. These results discourage the clinical use of a fibrin sealant in TKR. TRIAL REGISTRATION:Dutch Trial Register, NTR2500.

SUBMITTER: Verra WC

PROVIDER: S-EPMC6059473 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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The effect of a fibrin sealant on knee function after total knee replacement surgery. Results from the FIRST trial. A multicenter randomized controlled trial.

Verra Wiebe C WC van Hilten Joost A JA Honohan Áine Á van Zwet Erik W EW van der Bom Johanna G JG Nelissen Rob G H H RGHH

PloS one 20180725 7

<h4>Background</h4>Total knee replacement (TKR) is increasingly performed in short term hospital stay, making same day mobilization an important issue is after surgery. This implies little joint effusion by reducing intra-articular blood loss, which will enhance knee range of motion. The application of a topical fibrin sealant on the intraoperative bare bone and synovial tissue may contribute to better early full mobilization and thus improved functional outcomes. Since ambulation with a fully e ...[more]

PMID: 30044846

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Project description:BACKGROUND:Gait analysis can be used to measure variations in joint function in patients with knee osteoarthritis (OA), and is useful when observing longitudinal biomechanical changes following Total Knee Replacement (TKR) surgery. The Cardiff Classifier is an objective classification tool applied previously to examine the extent of biomechanical recovery following TKR. In this study, it is further developed to reveal the salient features that contribute to recovery towards healthy function. METHODS:Gait analysis was performed on 30 patients before and after TKR surgery, and 30 healthy controls. Median TKR follow-up time was 13 months. The combined application of principal component analysis (PCA) and the Cardiff Classifier defined 18 biomechanical features that discriminated OA from healthy gait. Statistical analysis tested whether these features were affected by TKR surgery and, if so, whether they recovered to values found for the controls. RESULTS:The Cardiff Classifier successfully discriminated between OA and healthy gait in all 60 cases. Of the 18 discriminatory features, only six (33%) were significantly affected by surgery, including features in all three planes of the ground reaction force (p<0.001), ankle dorsiflexion moment (p<0.001), hip adduction moment (p = 0.003), and transverse hip angle (p = 0.007). All but two (89%) of these features remained significantly different to those of the control group after surgery. CONCLUSIONS:This approach was able to discriminate gait biomechanics associated with knee OA. The ground reaction force provided the strongest discriminatory features. Despite increased gait velocity and improvements in self-reported pain and function, which would normally be clinical indicators of recovery, the majority of features were not affected by TKR surgery. This TKR cohort retained pre-operative gait patterns; reduced sagittal hip and knee moments, decreased knee flexion, increased hip flexion, and reduced hip adduction. The changes that were associated with surgery were predominantly found at the ankle and hip, rather than at the knee.

Project description:ObjectivesThe main objective was to investigate 5-year outcomes in patients with knee osteoarthritis, randomised to one of two non-surgical treatments.SettingTwo outpatient clinics.ParticipantsAt baseline, 100 patients with radiographic and symptomatic knee osteoarthritis not found eligible for knee replacement (KR) were included. Main exclusion criteria were average score above 75 of the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales pain, symptoms, function of daily living and quality of life; KOOS4 and average knee pain the previous week greater than 60 mm on a 100 mm visual analogue scale.InterventionsPatients were randomised to supervised non-surgical treatment consisting of patient education, supervised exercise, weight loss, insoles, and pain medication (the MEDIC treatment) or written advice. The 12-week MEDIC treatment included patient education, neuromuscular exercise, insoles and a dietary weight loss programme and/or pain medication if needed and written advice consisted of two leaflets.Primary and secondary outcome measuresPrimary outcome was 5-year mean change for KOOS4. Secondary outcomes included KOOS subscales, self-reported health, usage of pain medication and self-reported physical activity.ResultsThirty-nine (78%) and 36 (72%) from the MEDIC and written advice groups responded at 5 years. There were no between-group differences in KOOS4 (difference 5.3 (95% CI -1.5 to 12.1) or any secondary outcomes. However, the 95% CI included the minimal clinically important difference for the main outcome.Seventy-six percent of the MEDIC group and 66% of the written advice group experienced clinically important improvements in KOOS4.Fifteen patients (30%) from the MEDIC group and 17 (34%) from the written advice group received KR in the index knee. Undergoing KR did not result in a statistically significant greater improvement in KOOS4 (difference 6.1 (95% CI -1.1 to 13.4).ConclusionsNo statistically significant differences between supervised non-surgical treatment and written advice were demonstrated at 5 years. Most patients experienced clinically important improvements, irrespective of initial treatment strategy or KR.Trial registration numberNCT01535001; ClinicalTrials.gov.

Project description:BackgroundOptimal postoperative pain management is important to ensure patient comfort and early mobilization.MethodsIn this double-blind, placebo- and active-controlled, randomized clinical trial, we evaluated postoperative pain following knee replacement in patients receiving placebo, etoricoxib (90 or 120 mg), or ibuprofen 1800 mg daily for 7 days. Patients ≥18 years of age who had pain at rest ≥5 (0-10 Numerical Rating Scale [NRS]) after unilateral total knee replacement were randomly assigned to placebo (N = 98), etoricoxib 90 mg (N = 224), etoricoxib 120 mg (N = 230), or ibuprofen 1800 mg (N = 224) postoperatively. Co-primary endpoints included Average Pain Intensity Difference at Rest over Days 1-3 (0- to 10-point NRS) and Average Total Daily Dose of Morphine over Days 1-3. Pain upon movement was evaluated using Average Pain Intensity Difference upon Knee Flexion (0- to 10-point NRS). The primary objective was to demonstrate analgesic superiority for the etoricoxib doses vs. placebo; the secondary objective was to demonstrate that the analgesic effect of the etoricoxib doses was non-inferior to ibuprofen. Adverse experiences (AEs) including opioid-related AEs were evaluated.ResultsThe least squares (LS) mean (95% CI) differences from placebo for Pain Intensity Difference at Rest over Days 1-3 were -0.54 (-0.95, -0.14); -0.49 (-0.89, -0.08); and -0.45 (-0.85, -0.04) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.05 for etoricoxib vs. placebo). Differences in LS Geometric Mean Ratio morphine use over Days 1-3 from placebo were 0.66 (0.54, 0.82); 0.69 (0.56, 0.85); and 0.66 (0.53, 0.81) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.001 for etoricoxib vs. placebo). Differences in LS Mean Pain Intensity upon Knee Flexion were -0.37 (-0.85, 0.11); -0.46 (-0.94, 0.01); and -0.42 (-0.90, 0.06) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively. Opioid-related AEs occurred in 41.8%, 34.7%, 36.5%, and 36.3% of patients on placebo, etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively.ConclusionsPostoperative use of etoricoxib 90 and 120 mg in patients undergoing total knee replacement is both superior to placebo and non-inferior to ibuprofen in reducing pain at rest and also reduces opioid (morphine) consumption.Clinical trial registrationNCT00820027.

Project description:PurposeFor patients with end-stage knee osteoarthritis, joint replacement is a widely used and successful operation to help improve quality-of-life when non-operative measures have failed. For a significant proportion of patients there is a choice between a partial or total knee replacement. Decision aids can help people weigh up the need for and benefits of treatment against possible risks and side-effects. This study explored patients' experiences of deciding to undergo knee replacement surgery to identify information priorities, to inform a knee replacement decision aid.MethodsFour focus groups were held with 31 patients who were candidates for both partial and total knee replacement surgery. Two focus groups included patients with no prior knee replacement surgery (pre-surgery); two with patients with one knee already replaced and who were candidates for a second surgery on their other knee (post-surgery). Data were analysed using Framework Analysis.ResultsParticipants described a process of arriving at 'readiness for surgery' a turning point where the need for treatment outweighed their concerns. Referral and personal factors influenced their decision-making and expectations of surgery in the hope to return to a former self. Those with previous knee surgery offered insights into whether their expectations were met. 'Information for decisions' details the practicality and the optimal timing for the delivery of a knee replacement decision aid. In particular, participants would have valued hearing about the experiences of other patients and seeing detailed pictures of both surgical options. Information priorities were identified to include in a decision aid for knee replacement surgery.ConclusionsPatients' experiences of surgical decision-making have much in common with the Necessity-Concerns Framework. Whilst originally developed to understand drug treatment decisions and adherence, it provides a useful lens to understand decision-making about surgery. The use of a decision aid could enhance decision-making on knee replacement surgery. Ultimately, patients' understanding of the risks and benefits of both surgical options could be improved and in turn, help informed decision-making. The knee replacement decision aid is perceived as a useful tool to be associated with other detailed information resources as recommended.

Dataset Information

The effect of a fibrin sealant on knee function after total knee replacement surgery. Results from the FIRST trial. A multicenter randomized controlled trial.

Publications

The effect of a fibrin sealant on knee function after total knee replacement surgery. Results from the FIRST trial. A multicenter randomized controlled trial.

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