Background:
Responsiveness and the minimal important change (MIC) are important measurement properties to evaluate treatment effects and to interpret clinical trial results. The International Knee ...Documentation Committee (IKDC) Subjective Knee Form is a reliable and valid instrument for measuring patient-reported knee-specific symptoms, functioning, and sports activities in a population with meniscal tears. However, evidence on responsiveness is of limited methodological quality, and the MIC has not yet been established for patients with symptomatic meniscal tears.
Purpose:
To evaluate the responsiveness and determine the MIC of the IKDC for patients with meniscal tears.
Study Design:
Cohort study (design); Level of evidence 2.
Methods:
This study was part of the ESCAPE trial: a noninferiority multicenter randomized controlled trial comparing arthroscopic partial meniscectomy with physical therapy. Patients aged 45 to 70 years who were treated for a meniscal tear by arthroscopic partial meniscectomy or physical therapy completed the IKDC and 3 other questionnaires (RAND 36-Item Health Survey, EuroQol-5D-5L, and visual analog scales for pain) at baseline and 6-month follow-up. Responsiveness was evaluated by testing predefined hypotheses about the relation of the change in IKDC with regard to the change in the other self-reported outcomes. An external anchor question was used to distinguish patients reporting improvement versus no change in daily functioning. The MIC was determined by the optimal cutoff point in the receiver operating characteristic curve, which quantifies the IKDC score that best discriminated between patients with and without improvement in daily function.
Results:
Data from all 298 patients who completed baseline and 6-month follow-up questionnaires were analyzed. Responsiveness of the IKDC was confirmed in 7 of 10 predefined hypotheses about the change in IKDC score with regard to other patient-reported outcome measures. One hypothesis differed in the expected direction, while 2 hypotheses failed to meet the expected magnitude by 0.02 and 0.01 points. An MIC of 10.9 points was calculated for the IKDC of middle-aged and older patients with meniscal tears.
Conclusion:
This study showed that the IKDC is responsive to change among patients aged 45 to 70 years with meniscal tears, with an MIC of 10.9 points. This strengthens the value of the IKDC in quantifying treatment effects in this population.
Background:
It is unknown whether the treatment effects of partial meniscectomy and physical therapy differ when focusing on activities most valued by patients with degenerative meniscal tears.
...Purpose:
To compare partial meniscectomy with physical therapy in patients with a degenerative meniscal tear, focusing on patients’ most important functional limitations as the outcome.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
This study is part of the Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE) trial, a multicenter noninferiority randomized controlled trial conducted in 9 orthopaedic hospital departments in the Netherlands. The ESCAPE trial included 321 patients aged between 45 and 70 years with a symptomatic, magnetic resonance imaging–confirmed meniscal tear. Exclusion criteria were severe osteoarthritis, body mass index >35 kg/m2, locking of the knee, and prior knee surgery or knee instability due to an anterior or posterior cruciate ligament rupture. This study compared partial meniscectomy with physical therapy consisting of a supervised incremental exercise protocol of 16 sessions over 8 weeks. The main outcome measure was the Dutch-language equivalent of the Patient-Specific Functional Scale (PSFS), a secondary outcome measure of the ESCAPE trial. We used crude and adjusted linear mixed-model analyses to reveal the between-group differences over 24 months. We calculated the minimal important change for the PSFS using an anchor-based method.
Results:
After 24 months, 286 patients completed the follow-up. The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5). The crude overall between-group difference showed a –0.6-point difference (95% CI, –1.0 to –0.2; P = .004) in favor of the partial meniscectomy group. This improvement was statistically significant but not clinically meaningful, as the calculated minimal important change was 2.5 points on an 11-point scale.
Conclusion:
Both interventions were associated with a clinically meaningful improvement regarding patients’ most important functional limitations. Although partial meniscectomy was associated with a statistically larger improvement at some follow-up time points, the difference compared with physical therapy was small and clinically not meaningful at any follow-up time point.
Registration:
NCT01850719 (ClinicalTrials.gov identifier) and NTR3908 (the Netherlands Trial Register).
Optimizing return to work (RTW) after knee arthroplasty (KA) is becoming increasingly important due to a growing incidence of KA and poor RTW outcomes after KA. We developed the Back At work After ...Surgery (BAAS) clinical pathway for optimized RTW after KA. Since the effectiveness and cost analysis of the BAAS clinical pathway are still unknown, analysis on effectiveness and costs of BAAS is imperative.
This protocol paper has been written in line with the standards of Standard Protocol Items: Recommendations for Interventional Trails. To assess the effectiveness and cost-effectiveness for RTW, we will perform a multicenter prospective cohort study with patients who decided to receive a total KA (TKA) or an unicompartmental KA (UKA). To evaluate the effectiveness of BAAS regarding RTW, a comparison to usual care will be made using individual patient data on RTW from prospectively performed cohort studies in the Netherlands.
One of the strengths of this study is that the feasibility for the BAAS clinical pathway was tested at first hand. Also, we will use validated questionnaires and functional tests to assess the patient's recovery using robust outcomes. Moreover, the intervention was performed in two hospitals serving the targeted patient group and to reduce selection bias and improve generalizability. The limitations of this study protocol are that the lead author has an active role as a medical case manager (MCM) in one of the hospitals. Additionally, we will use the data from other prospective Dutch cohort studies to compare our findings regarding RTW to usual care. Since we will not perform an RCT, we will use propensity analysis to reduce the bias due to possible differences between these cohorts.
This study was retrospectively registered at clinicaltrails.gov ( https://clinicaltrials.gov/ct2/show/NCT05690347 , date of first registration: 19-01-2023).
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
AbstractObjectiveTo assess whether a clinically relevant difference exists in patients’ perceptions of symptoms, knee function, and ability to participate in sports over a period of two years after ...rupture of the anterior cruciate ligament (ACL) between two commonly used treatment regimens.DesignOpen labelled, multicentre, parallel randomised controlled trial (COMPARE).SettingSix hospitals in the Netherlands, between May 2011 and April 2016.ParticipantsPatients aged 18 to 65 with an acute rupture of the ACL, recruited from six hospitals. Patients were evaluated at three, six, nine, 12, and 24 months.Interventions85 patients were randomised to early ACL reconstruction and 82 to rehabilitation followed by optional delayed ACL reconstruction after a three month period (primary non-operative treatment).Main outcomesPatients’ perceptions of symptoms, knee function, and ability to participate in sporting activities were assessed with the International Knee Documentation Committee score (optimum score 100) at each time point over 24 months.ResultsBetween May 2011 and April 2016, 167 patients were enrolled in the study and randomised to one of two treatments (mean age 31.3; 67 (40.%) women), and 163 (98%) completed the trial. In the rehabilitation and optional delayed ACL reconstruction group, 41 (50%) patients underwent reconstruction during follow-up. After 24 months, the early ACL reconstruction group had a significantly better (P=0.026) but not clinically relevant International Knee Documentation Committee score (84.7 v 79.4 (difference between groups 5.3, 95% confidence interval 0.6 to 9.9). After three months of follow-up, the International Knee Documentation Committee score was significantly better (P=0.002) for the rehabilitation and optional delayed ACL reconstruction group (difference between groups −9.3, −14.6 to −4.0). After nine months of follow-up, the difference in the International Knee Documentation Committee score changed in favour of the early ACL reconstruction group. After 12 months, differences between the groups were smaller. In the early ACL reconstruction group, four re-ruptures and three ruptures of the contralateral ACL occurred during follow-up versus two re-ruptures and one rupture of the contralateral ACL in the rehabilitation and optional delayed ACL reconstruction group.ConclusionsIn patients with acute rupture of the ACL, those who underwent early surgical reconstruction, compared with rehabilitation followed by elective surgical reconstruction, had improved perceptions of symptoms, knee function, and ability to participate in sports at the two year follow-up. This finding was significant (P=0.026) but the clinical importance is unclear. Interpretation of the results of the study should consider that 50% of the patients randomised to the rehabilitation group did not need surgical reconstruction.Trial registrationNetherlands Trial Register NL 2618.
To conduct a cost-utility analysis for two commonly used treatment strategies for patients after ACL rupture; early ACL reconstruction (index) versus rehabilitation plus an optional reconstruction in ...case of persistent instability (comparator).
Patients aged between 18 and 65 years of age with a recent ACL rupture (<2 months) were randomised between either an early ACL reconstruction (index) or a rehabilitation plus an optional reconstruction in case of persistent instability (comparator) after 3 months of rehabilitation. A cost-utility analysis was performed to compare both treatments over a 2-year follow-up. Cost-effectiveness was calculated as incremental costs per quality-adjusted life year (QALY) gained, using two perspectives: the healthcare system perspective and societal perspective. The uncertainty for costs and health effects was assessed by means of non-parametric bootstrapping.
A total of 167 patients were included in the study, of which 85 were randomised to the early ACL reconstruction (index) group and 82 to the rehabilitation and optional reconstruction group (comparator). From the healthcare perspective it takes 48 460 € and from a societal perspective 78 179 €, to gain a QALY when performing early surgery compared with rehabilitation plus an optional reconstruction. This is unlikely to be cost-effective.
Routine early ACL reconstruction (index) is not considered cost-effective as compared with rehabilitation plus optional reconstruction for a standard ACL population (comparator) given the maximum willingness to pay of 20 000 €/QALY. Early recognition of the patients that have better outcome of early ACL reconstruction might make rehabilitation and optional reconstruction even more cost-effective.
Daily administration of vitamin D is important for maintaining bone homeostasis. The orthopedic community has shown increased interest in vitamin D supplementation and patient outcomes after ...fracture. The current study used data from a large hip fracture trial to determine the proportion of patients who consistently used vitamin D after hip fracture surgery and to determine whether supplementation was associated with improved health-related quality of life and reduced reoperation rates. The FAITH study is a multicenter trial of elderly patients with femoral neck fracture treated with internal fixation. The current study asked a subset of patients included in the FAITH study about vitamin D supplementation and categorized them as consistent users, inconsistent users, or nonusers. This study also evaluated whether supplementation was associated with improved quality of life and reduced reoperation rates. The final analysis included 573 patients (mean age, 74.1 years; female, 66.3%; nondis-placed fractures, 72.4%). A total of 18.7% of participants reported no use of vitamin D, 35.6% reported inconsistent use, and 45.7% reported consistent use. Adjusted analysis found that consistent supplementation was associated with a 2.42 increase of the Short Form-12 physical component score 12 months postoperatively (P=.033). However, supplementation was not associated with reduced reoperation rates (P=.386). Despite guidelines recommending vitamin D supplementation, a low proportion of elderly patients with hip fracture use vitamin D consistently, suggesting a need for additional strategies to promote compliance. This study found that the use of vitamin D was associated with a statistically significant but not clinically significant improvement in health-related quality of life after hip fracture. Further research is needed to confirm these findings. Orthopedics. 2017; 40(5):e868-e875..
Locomotor training improves function after a spinal cord injury both in experimental and clinical settings. The activity-dependent mechanisms underlying such improvement, however, are sparsely ...understood. Adult rats received a complete spinal cord transection (T9), and epidural stimulation (ES) electrodes were secured to the dura matter at L2. EMG electrodes were implanted bilaterally in selected muscles. Using a servo-controlled body weight support system for bipedal stepping, five rats were trained 7 d/week for 6 weeks (30 min/d) under quipazine (0.3 mg/kg) and ES (L2; 40 Hz). Nontrained rats were handled as trained rats but did not receive quipazine or ES. At the end of the experiment, a subset of rats was used for c-fos immunohistochemistry. Three trained and three nontrained rats stepped for 1 h (ES; no quipazine) and were returned to their cages for 1 h before intracardiac perfusion. All rats could step with ES and quipazine administration. The trained rats had higher and longer steps, narrower base of support at stance, and lower variability in EMG parameters than nontrained rats, and these properties approached that of noninjured controls. After 1 h of stepping, the number of FOS+ neurons was significantly lower in trained than nontrained rats throughout the extent of the lumbosacral segments. These results suggest that training reinforces the efficacy of specific sensorimotor pathways, resulting in a more selective and stable network of neurons that controls locomotion.
After complete spinal cord transections that removed all supraspinal inputs in adult rats, combinations of serotonergic agonists and epidural electrical stimulation were able to acutely transform ...spinal networks from nonfunctional to highly functional and adaptive states as early as 1 week after injury. Using kinematics, physiological and anatomical analyses, we found that these interventions could recruit specific populations of spinal circuits, refine their control via sensory input and functionally remodel these locomotor pathways when combined with training. The emergence of these new functional states enabled full weight-bearing treadmill locomotion in paralyzed rats that was almost indistinguishable from voluntary stepping. We propose that, in the absence of supraspinal input, spinal locomotion can emerge from a combination of central pattern-generating capability and the ability of these spinal circuits to use sensory afferent input to control stepping. These findings provide a strategy by which individuals with spinal cord injuries could regain substantial levels of motor control.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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