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Noorduyn JCA1, van de Graaf VA2, Willigenburg NW2, Butter IK2, de Gast A3, Mol BW4, Saris DBF5, Twisk JWR6, Poolman RW2
1OLVG, Physical Therapy / Orthopaedic Surgery, Amsterdam, Netherlands, 2OLVG, Orthopaedic Surgery, Amsterdam, Netherlands, 3Diakonessenhuis, Orthopedic Surgery, Utrecht, Netherlands, 4Monash University, School of Medicine, Melbourne, Australia, 5Mayo Clinic Minnesota Rochester, Orthopedic Surgery, Rochester, United States, 6Vrije Universiteit Amsterdam, Clinical Epidemiology and Biostatistics, Amsterdam, Netherlands
Background: Arthroscopic partial meniscectomy (APM) has been the most frequently performed orthopaedic surgical procedure for decades. While previous studies failed to demonstrate superiority of APM over physical therapy (PT), this has not evoked a major change in orthopaedic practice. Besides, no studies determined the cost-effectiveness of PT compared to APM yet. To strengthen current evidence, we compared APM and PT, combined with an economic evaluation, in participants with meniscal tears.
Purpose: The purpose of this trial-based economic evaluation is to determine whether PT is non-inferior (at least as effective and not more expensive) to APM in patients with non-obstructive meniscal tears.
Methods: This multicenter non-inferiority randomized controlled trial (RCT) recruited patients (45-70 years old) with a diagnosed non-obstructive meniscal tear. Patients were randomly assigned to APM or PT. The primary endpoint was patient reported knee function on the International Knee Documentation Committee (IKDC) questionnaire at 24 months, with a non-inferiority threshold of eight points. We calculated intervention effects by mixed modelling.
Subsequently, a non-inferiority economic evaluation from a societal perspective was conducted. For estimating costs, we collected healthcare costs, paid help costs, informal care costs, unpaid productivity costs, absenteeism and presenteeism. Treatment effects were quantified by the IKDC questionnaire and Quality-Adjusted Life-Years (QALYs). (ClinicalTrials.gov, NCT01850719).
Results: Between 2013 and 2015 we included 321 patients. The APM group (n=159) improved from 44.8 points (95%CI 42.2-47.3) to 71.5 points (95%CI 68.8-74.2) on the IKDC, mean difference (MD) 26.2 points (95%CI 23.2-29.2). The PT group (n=162) improved from 46.5 points (95% CI 44.3-48.8) to 67.7 points (95%CI 64.9-70.5) on the IKDC, MD 20.4 points (95%CI 17.5-23.2). Mixed modelling revealed that the adjusted treatment effect (4.4 points, 95%CI 1.3-7.5, p 0.01) was in favour of APM, but did not exceed the non-inferiority threshold of eight points.
Economic evaluation showed that PT was significantly less expensive (-€1803; 95%CI -€3,008 to -€838) and non-inferior to APM on the IKDC (-€449/point reduction, proportion CE-pairs in non-inferiority region 0.97). For QALYs, intention-to-treat yielded inconclusive results (-€61,584/QALY lost, proportion CE-pairs in non-inferiority region 0.89), but when we excluded protocol violators (e.g. patients who crossed over from PT to APM or patients with 16 PT sessions) PT was non-inferior to APM (-€148,866/QALY gained, proportion CE-pairs in non-inferiority region >0.99).
Conclusion(s): In middle-aged and older patients with a non-obstructive meniscal tear, PT is non-inferior to APM for both physical function and cost-effectiveness up to 24 months follow-up.
Implications: The results of this trial justify further de-implementation of APM from the guidelines and we strongly encourage PT as first choice treatment for middle aged and older patients with a non-obstructive meniscal tear.
Keywords: Meniscal tear, Physical therapy, Orthopaedic surgery
Funding acknowledgements: The Netherlands Organization for Health Research and Development (ZonMw)
Zilverenkruis Health Insurance
OLVG research foundation
Purpose: The purpose of this trial-based economic evaluation is to determine whether PT is non-inferior (at least as effective and not more expensive) to APM in patients with non-obstructive meniscal tears.
Methods: This multicenter non-inferiority randomized controlled trial (RCT) recruited patients (45-70 years old) with a diagnosed non-obstructive meniscal tear. Patients were randomly assigned to APM or PT. The primary endpoint was patient reported knee function on the International Knee Documentation Committee (IKDC) questionnaire at 24 months, with a non-inferiority threshold of eight points. We calculated intervention effects by mixed modelling.
Subsequently, a non-inferiority economic evaluation from a societal perspective was conducted. For estimating costs, we collected healthcare costs, paid help costs, informal care costs, unpaid productivity costs, absenteeism and presenteeism. Treatment effects were quantified by the IKDC questionnaire and Quality-Adjusted Life-Years (QALYs). (ClinicalTrials.gov, NCT01850719).
Results: Between 2013 and 2015 we included 321 patients. The APM group (n=159) improved from 44.8 points (95%CI 42.2-47.3) to 71.5 points (95%CI 68.8-74.2) on the IKDC, mean difference (MD) 26.2 points (95%CI 23.2-29.2). The PT group (n=162) improved from 46.5 points (95% CI 44.3-48.8) to 67.7 points (95%CI 64.9-70.5) on the IKDC, MD 20.4 points (95%CI 17.5-23.2). Mixed modelling revealed that the adjusted treatment effect (4.4 points, 95%CI 1.3-7.5, p 0.01) was in favour of APM, but did not exceed the non-inferiority threshold of eight points.
Economic evaluation showed that PT was significantly less expensive (-€1803; 95%CI -€3,008 to -€838) and non-inferior to APM on the IKDC (-€449/point reduction, proportion CE-pairs in non-inferiority region 0.97). For QALYs, intention-to-treat yielded inconclusive results (-€61,584/QALY lost, proportion CE-pairs in non-inferiority region 0.89), but when we excluded protocol violators (e.g. patients who crossed over from PT to APM or patients with 16 PT sessions) PT was non-inferior to APM (-€148,866/QALY gained, proportion CE-pairs in non-inferiority region >0.99).
Conclusion(s): In middle-aged and older patients with a non-obstructive meniscal tear, PT is non-inferior to APM for both physical function and cost-effectiveness up to 24 months follow-up.
Implications: The results of this trial justify further de-implementation of APM from the guidelines and we strongly encourage PT as first choice treatment for middle aged and older patients with a non-obstructive meniscal tear.
Keywords: Meniscal tear, Physical therapy, Orthopaedic surgery
Funding acknowledgements: The Netherlands Organization for Health Research and Development (ZonMw)
Zilverenkruis Health Insurance
OLVG research foundation
Topic: Musculoskeletal; Musculoskeletal: lower limb; Musculoskeletal
Ethics approval required: Yes
Institution: MEC-U
Ethics committee: Dhr. Gijsbertsen
Ethics number: NL44188.100.13
All authors, affiliations and abstracts have been published as submitted.
