The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up.
OBJECTIVE
To compare the efficacy of a 12-week non-surgical treatment program with usual care in patients with knee osteoarthritis (OA) not eligible for total knee replacement (TKR).


METHODS
This two-arm parallel group assessor-blinded randomized controlled trial (RCT) included 100 adults from secondary care with knee OA, confirmed by radiography (Kellgren-Lawrence grade ≥1), but not eligible for a TKR. The 12-week non-surgical treatment program consisted of individualized progressed neuromuscular exercise, patient education, insoles, dietary advice and prescription of pain medication if indicated, while usual care comprised two leaflets with information and advice on knee OA and recommended treatments. The primary outcome was the change from baseline to 12 months in the Knee injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the KOOS subscales of pain, symptoms, activities of daily living (ADL), and quality of life (QOL).


RESULTS
91% of the patients completed the 12 months follow-up on the primary outcome. Compared with usual care, patients undergoing the treatment program improved more in KOOS4 (adjusted mean difference (95% CI) of 9.6 (4.4-14.8)) with no serious treatment-related adverse events (AE). The number needed to treat (NNT), defined as the number of patients needed to treat for one person to improve 15% was 7.2. Secondary outcomes supported the primary findings.


CONCLUSIONS
In patients with mostly moderate to severe knee OA not eligible for TKR, a 12-week individualized, non-surgical treatment program is more efficacious at 12 months compared with usual care and has few treatment-related AE.


BACKGROUND
ClinicalTrials.gov (NCT01535001).
Orthopedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: sots@rn.dk.
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Skou
Orthopedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: sten.rasmussen@rn.dk.
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Rasmussen
Orthopedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: mogens.berg.laursen@rn.dk.
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MB
Laursen
Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: misr@rn.dk.
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MS
Rathleff
Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: LAN@hst.aau.dk.
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Arendt-Nielsen
Orthopedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: ohs@rn.dk.
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Simonsen
Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5230 Odense, Denmark. Electronic address: eroos@health.sdu.dk.
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Roos
D000203:Activities of Daily Living; D000368:Aged; D005081:Exercise Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009983:Orthopedic Equipment; D020370:Osteoarthritis, Knee / Q000000981:diagnostic imaging / Q000178:diet therapy / Q000188:drug therapy / Q000628:therapy*; D010353:Patient Education as Topic; D011788:Quality of Life; D011859:Radiography; D016896:Treatment Outcome
Knee; Osteoarthritis; Randomized controlled trial; Secondary care; Therapeutics