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Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data.

ABSTRACT: OBJECTIVES:Knee joint distraction (KJD) has been evaluated as a joint-preserving treatment to postpone total knee arthroplasty in knee osteoarthritis patients in three clinical trials. Since 2014 the treatment is used in regular care in some hospitals, which might lead to a deviation from the original indication and decreased treatment outcome. In this study, baseline characteristics, complications and clinical benefit are compared between patients treated in regular care and in clinical trials. METHODS:In our hospital, 84 patients were treated in regular care for 6 weeks with KJD. Surgical details, complications, and range of motion were assessed from patient hospital charts. Patient-reported outcome measures were evaluated in regular care before and one year after treatment. Trial patients (n = 62) were treated and followed as described in literature. RESULTS:Patient characteristics were not significantly different between groups, except for distraction duration (regular care 45.3±4.3; clinical trials 48.1±8.1 days; p = 0.019). Pin tract infections were the most occurring complication (70% regular care; 66% clinical trials), but there was no significant difference in treatment complications between groups (p>0.1). The range of motion was recovered within a year after treatment for both groups. WOMAC questionnaires showed statistically and clinically significant improvement for both groups (both p<0.001 and >15 points in all subscales) and no significant differences between groups (all differences p>0.05). After one year, 70% of patients were responders (regular care 61%, trial 75%; p = 0.120). Neither regular care compared to clinical trial, nor any other characteristic could predict clinical response. CONCLUSIONS:KJD as joint-preserving treatment in clinical practice, to postpone arthroplasty for end-stage knee osteoarthritis patient below the age of 65, results in an outcome similar to that thus far demonstrated in clinical trials. Longer follow-up in regular care is needed to test whether also long-term results remain beneficial and comparable to trial data.

SUBMITTER: Jansen MP

PROVIDER: S-EPMC6975543 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data.

Jansen Mylène P MP Mastbergen Simon C SC van Heerwaarden Ronald J RJ Spruijt Sander S van Empelen Michelle D MD Kester Esmee C EC Lafeber Floris P J G FPJG Custers Roel J H RJH

PloS one 20200122 1

<h4>Objectives</h4>Knee joint distraction (KJD) has been evaluated as a joint-preserving treatment to postpone total knee arthroplasty in knee osteoarthritis patients in three clinical trials. Since 2014 the treatment is used in regular care in some hospitals, which might lead to a deviation from the original indication and decreased treatment outcome. In this study, baseline characteristics, complications and clinical benefit are compared between patients treated in regular care and in clinical ...[more]

PMID: 31968005

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Project description:Osteoarthritis (OA) is the most common musculoskeletal disorder. Although joint replacement remains the standard of care for knee OA patients, knee joint distraction (KJD), which works by temporarily off-loading the joint for 6-8 weeks, is becoming a novel joint-sparing alternative for younger OA sufferers. The biological mechanisms behind KJD structural improvements remain poorly understood but likely involve joint-resident regenerative cells including multipotent stromal cells (MSCs). In this study, we hypothesized that KJD leads to beneficial cartilage-anabolic and anti-catabolic changes in joint-resident MSCs and investigated gene expression profiles of synovial fluid (SF) MSCs following KJD as compared with baseline. To obtain further insights into the effects of local biomechanics on MSCs present in late OA joints, SF MSC gene expression was studied in a separate OA arthroplasty cohort and compared with subchondral bone (SB) MSCs from medial (more loaded) and lateral (less loaded) femoral condyles from the same joints. In OA arthroplasty cohort (n = 12 patients), SF MSCs expressed lower levels of ossification- and hypotrophy-related genes [bone sialoprotein (IBSP), parathyroid hormone 1 receptor (PTH1R), and runt-related transcription factor 2 (RUNX2)] than did SB MSCs. Interestingly, SF MSCs expressed 5- to 50-fold higher levels of transcripts for classical extracellular matrix turnover molecules matrix metalloproteinase 1 (MMP1), a disintegrin and metalloproteinase with thrombospondin motifs 5 (ADAMTS5), and tissue inhibitor of metalloproteinase-3 (TIMP3), all (p < 0.05) potentially indicating greater cartilage remodeling ability of OA SF MSCs, compared with SB MSCs. In KJD cohort (n = 9 patients), joint off-loading resulted in sustained, significant increase in SF MSC colonies' sizes and densities and a notable transcript upregulation of key cartilage core protein aggrecan (ACAN) (weeks 3 and 6), as well as reduction in pro-inflammatory C-C motif chemokine ligand 2 (CCL2) expression (weeks 3 and 6). Additionally, early KJD changes (week 3) were marked by significant increases in MSC chondrogenic commitment markers gremlin 1 (GREM1) and growth differentiation factor 5 (GDF5). In combination, our results reveal distinct transcriptomes on joint-resident MSCs from different biomechanical environments and show that 6-week joint off-loading leads to transcriptional changes in SF MSCs that may be beneficial for cartilage regeneration. Biomechanical factors should be certainly considered in the development of novel MSC-based therapies for OA.

Project description:Osteoarthritis (OA) stands as a prevalent degenerative joint ailment, demanding immediate attention towards the development of efficacious therapeutic interventions. Presently, a definitive cure for OA remains elusive, and when conservative treatment modalities prove ineffective, resorting to a joint prosthesis becomes imperative. Temporary distraction emerges as a pivotal joint-preserving intervention in human OA patients, conferring both clinical amelioration and structural enhancements. Although extant clinical investigations exist, they are characterized by relatively modest sample sizes. Nonetheless, these studies furnish compelling evidence affirming that joint distraction engenders sustained clinical amelioration and structural refinement. Despite substantial strides in the last decade, a bibliometric analysis of joint distraction within the realm of osteoarthritis treatment research has been conspicuously absent. In this context, we have undertaken a comparative investigation utilizing bibliometric methodologies to scrutinize the landscape of joint distraction within osteoarthritis treatment. Our comprehensive analysis encompassed 469 scholarly articles. Our findings evince a consistent escalation in global research interest and publication output pertaining to this subject. The United States emerged as the frontrunner in international collaboration, publication count, and citation frequency, underscoring its preeminence in this domain. The journal "Osteoarthritis and Cartilage" emerged as the principal platform for disseminating research output on this subject. Notably, Mastbergen SC emerged as the most prolific contributor in terms of authorship. The identified keywords predominantly revolved around non-surgical interventions and joint arthroscopy procedures. This bibliometric analysis, augmented by visual representations, furnishes invaluable insights into the evolutionary trajectory of joint distraction as an osteoarthritis treatment modality spanning from 2003 to 2023. These insights will serve as a compass for the scientific community, facilitating further exploration in this promising domain.

Project description:IntroductionThis study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis (KOA) and evaluated safety.MethodsA multi-centre, non-blinded, parallel-group, randomised controlled trial compared moxibustion with usual care (UC) in KOA. 212 South Korean patients aged 40-70 were recruited from 2011-12, stratified by mild (Kellgren/Lawrence scale grades 0/1) and moderate-severe KOA (grades 2/3/4), and randomly allocated to moxibustion or UC for four weeks. Moxibustion involved burning mugwort devices over acupuncture and Ashi points in affected knee(s). UC was allowed. Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC), Short Form 36 Health Survey (SF-36v2), Beck Depression Inventory (BDI), physical performance test, pain numeric rating scale (NRS) and adverse events were evaluated at 5 and 13 weeks. K-WOMAC global score at 5 weeks was the primary outcome.Results102 patients (73 mild, 29 moderate-severe) were allocated to moxibustion, 110 (77 mild, 33 moderate-severe) to UC. K-WOMAC global score (moxibustion 25.42+/-SD 19.26, UC 33.60+/-17.91, p<0.01, effect size?=?0.0477), NRS (moxibustion 44.77+/-22.73, UC 56.23+/-17.71, p<0.01, effect size?=?0.0073) and timed-stand test (moxibustion 24.79+/-9.76, UC 25.24+/-8.84, p?=?0.0486, effect size ?=?0.0021) were improved by moxibustion at 5 weeks. The primary outcome improved for mild but not moderate-severe KOA. At 13 weeks, moxibustion significantly improved the K-WOMAC global score and NRS. Moxibustion improved SF-36 physical component summary (p?=?0.0299), bodily pain (p?=?0.0003), physical functioning (p?=?0.0025) and social functioning (p?=?0.0418) at 5 weeks, with no difference in mental component summary at 5 and 13 weeks. BDI showed no difference (p?=?0.34) at 5 weeks. After 1158 moxibustion treatments, 121 adverse events included first (n?=?6) and second degree (n?=?113) burns, pruritus and fatigue (n?=?2).ConclusionsMoxibustion may improve pain, function and quality of life in KOA patients, but adverse events are common. Limitations included no sham control or blinding.Trial registrationClinical Research Information Service (CRIS) KCT0000130.

Dataset Information

Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data.

Publications

Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data.

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