Dataset Information

Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial.

ABSTRACT:

Objectives

The main objective was to investigate 5-year outcomes in patients with knee osteoarthritis, randomised to one of two non-surgical treatments.

Setting

Two outpatient clinics.

Participants

At 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.

Interventions

Patients 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 measures

Primary 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.

Results

Thirty-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).

Conclusions

No 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 number

NCT01535001; ClinicalTrials.gov.

SUBMITTER: Larsen JB

PROVIDER: S-EPMC9703324 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial.

Larsen Jesper Bie JB Roos Ewa M EM Laursen Mogens M Holden Sinead S Johansen Martin Nygaard MN Rathleff Michael Skovdal MS Arendt-Nielsen Lars L Rasmussen Sten S Skou Søren T ST

BMJ open 20221125 11

<h4>Objectives</h4>The main objective was to investigate 5-year outcomes in patients with knee osteoarthritis, randomised to one of two non-surgical treatments.<h4>Setting</h4>Two outpatient clinics.<h4>Participants</h4>At 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, fun ...[more]

PMID: 36428014

Similar Datasets

Project description:BackgroundThe Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway.MethodsParticipants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0-10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon.ResultsOverall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and - 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94.ConclusionsThe magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years.Trial registrationISRCTN: 92,545,361.

Project description:INTRODUCTION:It is recommended that non-operative treatment of knee osteoarthritis (KOA) should be individually tailored and include multiple treatment modalities. Despite these recommendations, no one has yet investigated the efficacy of combining several non-surgical treatment modalities in a randomised controlled study. The purpose of this randomised controlled study is to examine if an optimised, combined non-surgical treatment programme results in greater improvements in pain, function and quality of life in comparison with usual care in patients with KOA who are not eligible for total knee arthroplasty (TKA). METHODS AND ANALYSIS:This study will include 100 consecutive patients from the North Denmark Region not eligible for TKA with radiographic KOA (K-L grade ?1) and mean pain during the previous week of ?60 mm (0-100). The participants will be randomised to receive either a 12-week non-surgical treatment programme consisting of patient education, exercise, diet, insoles, paracetamol and/or NSAIDs or usual care (two information leaflets containing information on KOA and advice regarding the above non-surgical treatment). The primary outcome will be the change from baseline to 12 months on the self-report questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS)(4) defined as the average score for the subscale scores for pain, symptoms, activities of daily living and quality of life. Secondary outcomes include the five individual KOOS subscale scores, pain on a 100 mm Visual Analogue Scale, EQ-5D, self-efficacy, pain pressure thresholds, postural control and isometric knee flexion and knee extension strength. ETHICS AND DISSEMINATION:This study was approved by the local Ethics Committee of The North Denmark Region (N-20110085) and the protocol conforms to the principles of the Declaration of Helsinki. Data collection will be completed by April 2014. Publications will be ready for submission in the summer of 2014. TRIAL REGISTRATION NUMBER:This study is registered with http://clinicaltrials.gov (NCT01535001).

Project description:Background and aimsThe incidence of total knee arthroplasty (TKA) is increasing, especially among younger working-age patients. However, dissatisfaction rates in this population are higher than among older patients. The aim of this study was to assess the rates of dissatisfaction and persistent pain after TKA and to evaluate those factors that predict these outcomes.Material and methodsIn total, 186 patients undergoing unilateral TKA aged 65 years or less were enrolled into this prospective observational study with 2-year follow-up. To assess the outcome, the visual analogue scales regarding satisfaction and persistent pain at rest and during exercise were used. In addition, the association between patients´ demographics, radiographic severity of knee osteoarthritis (OA), patient-reported outcome measures (PROMs) and dissatisfaction and persistent pain were tested by univariate logistic regression analysis. Mild OA was defined as Kellgren-Lawrence (KL) grade 2 and severe OA as KL grade 3-4. Furthermore, multiple logistic regression analysis was also conducted to test statistically significant relations.ResultsAfter 2 years, 12 % (n = 23) of patients were dissatisfied with the outcome of TKA, 27 % (n = 50) reported persistent pain during exercise and 10 % (n = 18) at rest. Patients with mild knee OA were significantly more dissatisfied (28.6 %) than patients with more severe OA (8.7 %) (p = 0.003). Younger patients had an increased risk for both dissatisfaction and persistent pain. Apart from KOOS Quality of Life, poor preoperative KOOS subscores were also predictive for these outcomes.ConclusionMild radiographic knee OA was the main predicting factor for dissatisfaction after TKA. Thus, performing TKA for such patients should be carefully considered. Furthermore, these patients should be informed about the increased risk for dissatisfaction and the same seems to apply to younger patients. Interestingly, when TKA is performed for patients with more severe knee OA, the satisfaction rates seem to be somewhat higher than those previously reported.Trial registrationThe study was retrospectively registered with ClinicalTrials.gov (registration number NCT03233620 ) on 28 July 2017.

Project description:Introduction:The aim of this work is to compare in a retrospective study, the radiological results of three series of different total knee replacements performed using Orthopilot computer-based alignment system (Group A, 31 patients), a totally intramedullary alignment system (Group B, 34 patients) and a totally extramedullary alignment system (Group C, 32 patients). Materials and methods:At a medium follow-up of 15 years, all patients underwent call interview for clinical update. Of the 115 patients initially enrolled in the study, only 97 were available for radiological assessment. Both standing long-leg antero-posterior radiographs and lateral radiographs of the knee had been taken for every patient at 1 year-follow-up and at the last follow-up. Results:At the last follow-up, the mean hip-knee-ankle angle (HKA) was 179.1° (range: 176°-184°) for group A, 178.6° (range: 173°-186°) for group B and 177.8° (range: 172°-186°) for group C with no statistically significant difference among the 3 groups. The mean frontal femoral component angle (FFC) was 90.5° (range: 87°-94°) for group A, 91.05° (range: 85°-95°) for group B and 91.19° (range: 85°-96°) for group C and there was no statistically significant difference among the three groups. The mean frontal tibial component angle (FTC) was 89.9° (range: 83°-97°) for group A, 90.6° (range: 87°-95°) for group B and 90.8° (range: 86°-95°) for group C and there was no statistically significant difference among the three groups. The mean tibial component inclination in the sagittal plane was 1° (range: 3°-0°) for group A, 3.6° (range: 7°-0°) for group B and 3.1° (range: 6°-0°) for group C. Discussion and conclusion:Our results demonstrated statistically significant differences between computer-assisted and extramedullary group, in favour of navigated group in terms of implant position and mechanical alignment. Computer-assisted group showed superior but not statistically significant differences compared to intramedullary alignment system in terms of implant position and mechanical alignment. We advocate the use of computer-assisted system routinely in total knee replacement. As an alternative, we suggest the use of intramedullary system.

Dataset Information

Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial.

Objectives

Setting

Participants

Interventions

Primary and secondary outcome measures

Results

Conclusions

Trial registration number

Publications

Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets