scholarly journals Responsiveness and Minimal Important Change of the IKDC of Middle-Aged and Older Patients With a Meniscal Tear

2019 ◽  
Vol 47 (2) ◽  
pp. 364-371 ◽  
Author(s):  
Julia C.A. Noorduyn ◽  
Victor A. van de Graaf ◽  
Lidwine B. Mokkink ◽  
Nienke W. Willigenburg ◽  
Rudolf W. Poolman ◽  
...  

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.

2019 ◽  
Vol 53 (23) ◽  
pp. 1474-1478 ◽  
Author(s):  
Ewa M Roos ◽  
Eleanor Boyle ◽  
Richard B Frobell ◽  
L Stefan Lohmander ◽  
Lina Holm Ingelsrud

IntroductionIn sports physiotherapy, medicine and orthopaedic randomised controlled trials (RCT), the investigators (and readers) focus on the difference between groups in change scores from baseline to follow-up. Mean score changes are difficult to interpret (‘is an improvement of 20 units good?’), and follow-up scores may be more meaningful. We investigated how applying three different responder criteria to change and follow-up scores would affect the ‘outcome’ of RCTs. Responder criteria refers to participants’ perceptions of how the intervention affected them.MethodsWe applied three different criteria—minimal important change (MIC), patient acceptable symptom state (PASS) and treatment failure (TF)—to the aggregate Knee injury and Osteoarthritis Outcome Score (KOOS4) and the five KOOS subscales, the primary and secondary outcomes of the KANON trial (ISRCTN84752559). This trial included young active adults with an acute ACL injury and compared two treatment strategies: exercise therapy plus early reconstructive surgery, and exercise therapy plus delayed reconstructive surgery, if needed.ResultsMIC: At 2 years, more than 90% in the two treatment arms reported themselves to be minimally but importantly improved for the primary outcome KOOS4. PASS: About 50% of participants in both treatment arms reported their KOOS4 follow-up scores to be satisfactory. TF: Almost 10% of participants in both treatment arms found their outcomes so unsatisfactory that they thought their treatment had failed. There were no statistically significant or meaningful differences between treatment arms using these criteria.ConclusionWe applied change criteria as well as cross-sectional follow-up criteria to interpret trial outcomes with more clinical focus. We suggest researchers apply MIC, PASS and TF thresholds to enhance interpretation of KOOS and other patient-reported scores. The findings from this study can improve shared decision-making processes for people with an acute ACL injury.


Swiss Surgery ◽  
2002 ◽  
Vol 8 (3) ◽  
pp. 113-120 ◽  
Author(s):  
Ménétrey ◽  
Siegrist ◽  
Fritschy

Purpose: Meniscectomy in the older patient remains a controversial topic. The aim of our study is to assess the mid-term outcome of arthroscopic partial medial meniscectomy in patients over fifty years of age and attempt to retrospectively identify symptoms and/or findings on examination which can differentiate between non-degenerative medial meniscal tears versus degenerative meniscal changes. Materials and Methods: Thirty-two patients over the age of fifty who had undergone arthroscopic medial partial meniscectomy, were reviewed. The average age was 60 (51-74 yrs) and the average follow-up was six years (3-7 yrs). Based upon the intra-operative findings, patients were divided into two groups: (1) non-degenerative meniscal tears (NDM; n = 12) and (2) degenerative meniscal changes (DM; n = 20). Our outcome measurements were with the HSS knee score, a satisfaction score, and weight-bearing X-rays. Results: In the NDM group, eleven patients were rated excellent or good, and one was rated poor. In the DM group, three patients were rated as excellent or good, eight as fair, and nine as poor. The HSS score was 97 +/- 4.6 for the NDM group and 85 +/- 9.5 for the DM group. The average satisfaction score was 9.2 +/- 0.7 (very satisfied) for the NDM group and 5.8 +/- 2.6 (fairly satisfied) for the DM group. There was no significant difference between the NDM and the DM groups with regards to pre-operative symptoms and signs, except for the McMurray sign, which was found to be positive in 83% of NDM cases versus 25% of DM cases (sensitivity = 83%). Using only these data, the McMurray sign was 67% specific for NDM. Conclusions: Arthroscopic medial meniscectomy in older patients provides 90% good results six years after a non-degenerative meniscal tear, but only 20% of good results after a degenerative meniscal tear. However, based on this study, neither symptoms nor physical examination are able to differentiate between traumatic meniscal tears and degenerative meniscal changes in older patients. A positive McMurray's sign favors the diagnosis of a traumatic tear. However, a specificity of this test of only 67% as shown in our data questions its utility in clinical decision-making.


2020 ◽  
Vol 8 (10) ◽  
pp. 232596712095439
Author(s):  
Julia C.A. Noorduyn ◽  
Tess Glastra van Loon ◽  
Victor A. van de Graaf ◽  
Nienke W. Willigenburg ◽  
Ise K. Butter ◽  
...  

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).


2019 ◽  
Vol 54 (9) ◽  
pp. 538-545 ◽  
Author(s):  
Victor A van de Graaf ◽  
Johanna M van Dongen ◽  
Nienke W Willigenburg ◽  
Julia C A Noorduyn ◽  
Ise K Butter ◽  
...  

ObjectivesTo examine whether physical therapy (PT) is cost-effective compared with arthroscopic partial meniscectomy (APM) in patients with a non-obstructive meniscal tear, we performed a full trial-based economic evaluation from a societal perspective. In a secondary analysis—this paper—we examined whether PT is non-inferior to APM.MethodsWe recruited patients aged 45–70 years with a non-obstructive meniscal tear in nine Dutch hospitals. Resource use was measured using web-based questionnaires. Measures of effectiveness included knee function using the International Knee Documentation Committee (IKDC) and quality-adjusted life-years (QALYs). Follow-up was 24 months. Uncertainty was assessed using bootstrapping techniques. The non-inferiority margins for societal costs, the IKDC and QALYs, were €670, 8 points and 0.057 points, respectively.ResultsWe randomly assigned 321 patients to PT (n=162) or APM (n=159). PT was associated with significantly lower costs after 24 months compared with APM (−€1803; 95% CI −€3008 to −€838). The probability of PT being cost-effective compared with APM was 1.00 at a willingness to pay of €0/unit of effect for the IKDC (knee function) and QALYs (quality of life) and decreased with increasing values of willingness to pay. The probability that PT is non-inferior to APM was 0.97 for all non-inferiority margins for the IKDC and 0.89 for QALYs.ConclusionsThe probability of PT being cost-effective compared with APM was relatively high at reasonable values of willingness to pay for the IKDC and QALYs. Also, PT had a relatively high probability of being non-inferior to APM for both outcomes. This warrants further deimplementation of APM in patients with non-obstructive meniscal tears.Trial registration numbersNCT01850719 and NTR3908.


2020 ◽  
Author(s):  
Hongwu Zhuo ◽  
Fugui Zhu ◽  
Ling Pan ◽  
Jian Li

Abstract BackgroundTo determine the clinical and MRI outcomes after modified arthroscopic all-inside repair for lateral meniscal tears anterior to the popliteal hiatus.MethodsPatients who underwent modified arthroscopic all-inside repair for lateral meniscal tears anterior to the popliteal hiatus at our institution were identified. The clinical assessment consisted of the symptoms of meniscal tears, McMurray test, and patient-reported outcomes (Lysholm score, Tegner score, and International Knee Documentation Committee (IKDC) score). The status of meniscal healing was assessed using postoperative MRI scan.ResultsTwenty-five patients met the inclusion criteria. The mean age was 27.60 ± 8.37 years (range, 16 to 43 years). The mean follow-up period was 26.04 ± 2.88 months (range, 24 to 36 months). At final follow-up, the symptoms of meniscal tears disappeared in 23 patients with a negative McMurray test. The patient-reported outcomes of Lysholm, Tegner, and IKDC score improved significantly compared to the preoperative values (P = 0.001). No significant differences were observed in postoperative clinical outcomes between patients with or without concomitant ACL tears (P > 0.05). Postoperative MRI scan showed that the repaired lateral meniscus anterior to the popliteal hiatus obtained healing in 23 (92.0%) patients and no healing in 2 patients.ConclusionThis modified arthroscopic all-inside repair technique was safe and effective to treat lateral meniscal tears anterior to the popliteal hiatus, resulting in significantly improved clinical outcomes with a high healing rate and low risk of adjacent structures injury.


2021 ◽  
Vol 26 (01) ◽  
pp. 14-15

van de Graaf VA et al. How do the costs of physical therapy and arthroscopic partial meniscectomy compare? A trial-based economic evaluation of two treatments in patients with meniscal tears alongside the ESCAPE study. Br J Sports Med 2020; 54: 538–546 Jedes Jahr werden weltweit 2 Millionen Knieoperationen durchgeführt, die mit hohen Kosten verbunden sind. Obwohl nicht nachgewiesen ist, dass Operationen gegenüber einer konservativen Behandlung Vorteile bringen, nimmt die Zahl der Operationen nur langsam ab. Van de Graaf et al. untersuchten, ob eine Physiotherapie im Vergleich zur arthroskopischen partiellen Meniskektomie bei Patienten mit nichtobstruktiven Meniskusrissen kosteneffektiv ist.


Author(s):  
Berend Terluin ◽  
Ewa M. Roos ◽  
Caroline B. Terwee ◽  
Jonas B. Thorlund ◽  
Lina H. Ingelsrud

Abstract Purpose The minimal important change (MIC) of a patient-reported outcome measure (PROM) is often suspected to be baseline dependent, typically in the sense that patients who are in a poorer baseline health condition need greater improvement to qualify as minimally important. Testing MIC baseline dependency is commonly performed by creating two or more subgroups, stratified on the baseline PROM score. This study’s purpose was to show that this practice produces biased subgroup MIC estimates resulting in spurious MIC baseline dependency, and to develop alternative methods to evaluate MIC baseline dependency. Methods Datasets with PROM baseline and follow-up scores and transition ratings were simulated with and without MIC baseline dependency. Mean change MICs, ROC-based MICs, predictive MICs, and adjusted MICs were estimated before and after stratification on the baseline score. Three alternative methods were developed and evaluated. The methods were applied in a real data example for illustration. Results Baseline stratification resulted in biased subgroup MIC estimates and the false impression of MIC baseline dependency, due to redistribution of measurement error. Two of the alternative methods require a second baseline measurement with the same PROM or another correlated PROM. The third method involves the construction of two parallel tests based on splitting the PROM’s item set. Two methods could be applied to the real data. Conclusion MIC baseline dependency should not be tested in subgroups based on stratification on the baseline PROM score. Instead, one or more of the suggested alternative methods should be used.


2019 ◽  
Vol 47 (10) ◽  
pp. 2412-2419
Author(s):  
Alejandro Lizaur-Utrilla ◽  
Francisco A. Miralles-Muñoz ◽  
Santiago Gonzalez-Parreño ◽  
Fernando A. Lopez-Prats

Background: There is controversy about the benefit of arthroscopic partial meniscectomy (APM) for degenerative lesions in middle-aged patients. Purpose: To compare satisfaction with APM between middle-aged patients with no or mild knee osteoarthritis (OA) and a degenerative meniscal tear and those with a traumatic tear. Study Design: Cohort study; Level of evidence, 2. Methods: A comparative prospective study at 5 years of middle-aged patients (45-60 years old) with no or mild OA undergoing APM for degenerative (n = 115) or traumatic (n = 143) tears was conducted. Patient satisfaction was measured by a 5-point Likert scale and functional outcomes by the Knee injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Univariate and multivariate regression analyses were used to identify factors correlating with patient-reported satisfaction at 5 years postoperatively. Results: Baseline patient characteristics were not different between groups. At the 5-year evaluation, the satisfaction rate in the traumatic and degenerative groups was 68.5% versus 71.3%, respectively ( P = .365). Patient satisfaction was significantly associated with functional outcomes ( r = 0.69; P = .024). In the degenerative group, 43 patients (37.4%) had OA progression to Kellgren-Lawrence (K-L) grade 2 or 3, but only 24 patients (20.8%) had a symptomatic knee at final follow-up. Multivariate regression analysis for patient dissatisfaction at 5-year follow-up showed the following significant independent factors: female sex (odds ratio [OR], 1.6 [95% CI, 1.1-2.3]; P = .018), body mass index >30 kg/m2 (OR, 2.6 [95% CI, 1.7-4.9]; P = .035), lateral meniscal tears (OR, 0.6 [95% CI, 0.1-0.9]; P = .039), and OA progression to K-L grade ≥2 at final follow-up (OR, 1.4 [95% CI, 1.2-2.6]; P = .014). At the final evaluation, there were no significant differences between groups in pain scores ( P = .648), WOMAC scores ( P = .083), or KOOS-4 scores ( P = .187). Likewise, there were no significant differences in the KOOS subscores for Pain ( P = .144), Symptoms ( P = .097), or Sports/Recreation ( P = .150). Although the degenerative group had significantly higher subscores for Activities of Daily Living ( P = .001) and Quality of Life ( P = .004), the differences were considered not clinically meaningful. Conclusion: There were no meaningful differences in patient satisfaction or clinical outcomes between patients with traumatic and degenerative tears and no or mild OA. Predictors of dissatisfaction with APM were female sex, obesity, and lateral meniscal tears. Our findings suggested that APM was an effective medium-term option to relieve pain and recover function in middle-aged patients with degenerative meniscal tears, without obvious OA, and with failed prior physical therapy.


2019 ◽  
Vol 33 (08) ◽  
pp. 785-791 ◽  
Author(s):  
Vishal S. Desai ◽  
Isabella T. Wu ◽  
Christopher L. Camp ◽  
Bruce A. Levy ◽  
Michael J. Stuart ◽  
...  

AbstractThere is limited evidence guiding management of medial collateral ligament (MCL) avulsions or functional disruptions distal to the medial joint line. This study aims to determine outcomes of a series of patients with grade III distal MCL injuries managed with acute surgical repair. Patients with grade III, distal MCL injuries, with or without multiligament involvement were identified. Demographic, clinical examination, and midterm patient-reported outcomes (PRO) data were collected. Clinical follow-up included physical examination and ligamentous stress testing at a minimum of 6 months. PROs included Lysholm's knee scoring scale, Tegner's activity score, and subjective International Knee Documentation Committee (IKDC) scores at minimum of 2 years follow-up. Of the 24 eligible patients, outcomes data were available for 20 (83%). Of the 20 included patients, 16 had a concomitant anterior cruciate ligament (ACL) injury, 3 had ACL and posterior cruciate ligament (PCL) injuries, and 1 had an isolated MCL injury. Mean time from injury to surgery was 5 weeks. At mean clinical follow-up of 20.3 months, all patients showed valgus stability and satisfactory range of motion (ROM). Anteroposterior stability was normal in all but one patient who demonstrated a 2+ posterior drawer but with firm end points. At a mean follow-up of 5.7 years for PROs, mean Lysholm's score was 91.5 (standard deviation [SD] = 12.2), median Tegner's activity score was 7 (range, 4–9), and mean subjective IKDC score was 88.8 (SD: 9.9). The surgical repair of grade III distal MCL injuries delivered satisfactory clinical and functional outcomes. Future comparative studies with larger patient samples are needed.


Sign in / Sign up

Export Citation Format

Share Document