Knee Joint Distraction as an Alternative Surgical Treatment for Osteoarthritis: Rationale and Design of two Randomized Controlled Trials (vs High Tibial Osteotomy and Total Knee Prosthesis)

Wiegant, K.; Heerwaarden, Ronald van; Woude, Jan-Ton van der; Custers, Roel J.H.; Emans, Pieter J.; Kuchuk, N.O.; Mastbergen, S.C.; Lafeber, F.P.

doi:10.17554/j.issn.2311-5106.2015.02.91

Cited by 17 publications

(15 citation statements)

References 38 publications

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“…A sample size calculation was performed for the primary RCT. 24 For the present study, a convenience sample was used, aiming for a response rate >80%. Demographic data, and preand postoperative sport and work participation were analyzed using descriptive statistics.…”

Section: Discussionmentioning

confidence: 99%

“…With KJD, an external distraction device creates a temporary load reduction between focal areas of cartilage surfaces in the knee. 24 Intema et al showed that KJD treatment resulted in radiographic improvement of joint space width (JSW) and increased cartilage thickness on MRI, indicative of tissue structure modification that may have beneficial effects on patients' knee pain and symptoms. 25 A preserved treatment effect up to 5 years has been described with increased minimum JSW at 5-year post-treatment compared with pretreatment.…”

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confidence: 99%

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Return to Sport and Work after Randomization for Knee Distraction versus High Tibial Osteotomy: Is There a Difference?

et al. 2020

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Knee joint distraction (KJD) is a novel technique for relatively young knee osteoarthritis (OA) patients. With KJD, an external distraction device creates temporary total absence of contact between cartilage surfaces, which results in pain relief and possibly limits the progression of knee OA. Recently, KJD showed similar clinical outcomes compared with high tibial osteotomy (HTO). Yet, no comparative data exist regarding return to sport (RTS) and return to work (RTW) after KJD. Therefore, our aim was to compare RTS and RTW between KJD and HTO. We performed a cross-sectional follow-up study in patients <65 years who previously participated in a randomized controlled trial comparing KJD and HTO. Out of 62 eligible patients, 55 patients responded and 51 completed the questionnaire (16 KJDs and 35 HTOs) at 5-year follow-up. The primary outcome measures were the percentages of RTS and RTW. Secondary outcome measures included time to RTS/RTW, and pre- and postoperative Tegner's (higher is more active), and Work Osteoarthritis or Joint-Replacement Questionnaire (WORQ) scores (higher is better work ability). Patients' baseline characteristics did not differ. Total 1 year after KJD, 79% returned to sport versus 80% after HTO (not significant [n.s.]). RTS <6 months was 73 and 75%, respectively (n.s.). RTW 1 year after KJD was 94 versus 97% after HTO (n.s.), and 91 versus 87% <6 months (n.s.). The median Tegner's score decreased from 5.0 to 3.5 after KJD, and from 5.0 to 3.0 after HTO (n.s.). The mean WORQ score improvement was higher after HTO (16 ± 16) than after KJD (6 ± 13; p = 0.04). Thus, no differences were found for sport and work participation between KJD and HTO in our small, though first ever, cohort. Overall, these findings may support further investigation into KJD as a possible joint-preserving option for challenging “young” knee OA patients. The level of evidence is III.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Return to Sport and Work after Randomization for Knee Distraction versus High Tibial Osteotomy: Is There a Difference?

et al. 2020

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“…Recently, 42 patients have been treated with KJD in 2 randomized controlled trials comparing KJD with high tibial osteotomy and with TKA. 26 Based on such numbers a prediction of failure to KJD might be found in the future. However, in over a 110 patients treated with joint distraction in case of ankle osteoarthritis only female gender appeared predictive of failure.…”

Section: Discussionmentioning

confidence: 99%

Five-Year Follow-up of Knee Joint Distraction: Clinical Benefit and Cartilaginous Tissue Repair in an Open Uncontrolled Prospective Study

et al. 2016

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Objective In end-stage knee osteoarthritis, total knee arthroplasty (TKA) may finally become inevitable. At a relatively young age, this comes with the risk of future revision surgery. Therefore, in these cases, joint preserving surgery such as knee joint distraction (KJD) is preferred. Here we present 5-year follow-up data of KJD. Design Patients ( n = 20; age <60 years) with conservative therapy resistant tibiofemoral osteoarthritis considered for TKA were treated. Clinical evaluation was performed by questionnaires. Change in cartilage thickness was quantified on radiographs and magnetic resonance images (MRI). The 5-year changes after KJD were evaluated and compared with the natural progression of osteoarthritis using Osteoarthritis Initiative data. Results Five-years posttreatment, patients still reported clinical improvement from baseline: ΔWOMAC (Western Ontario and McMaster Universities Arthritis Index) +21.1 points (95% CI +8.9 to +33.3; P = 0.002), ΔVAS (visual analogue scale score) pain -27.6 mm (95%CI -13.3 to -42.0; P < 0.001), and minimum radiographic joint space width (JSW) of the most affected compartment (MAC) remained increased as well: Δ +0.43 mm (95% CI +0.02 to +0.84; P = 0.040). Improvement of mean JSW (x-ray) and mean cartilage thickness (MRI) of the MAC, were not statistically different from baseline anymore (Δ +0.26 mm; P = 0.370, and Δ +0.23 mm; P = 0.177). Multivariable linear regression analysis indicated that KJD treatment was associated with significantly less progression in mean and min JSW (x-ray) and mean cartilage thickness (MRI) compared with natural progression (all Ps <0.001). Conclusions KJD treatment results in prolonged clinical benefit, potentially explained by an initial boost of cartilaginous tissue repair that provides a long-term tissue structure benefit as compared to natural progression. Level of evidence, II.

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“…All inclusion aspects have been described in detail for all three studies, previously. [8,13,14,16] All trials were granted ethical approval by the medical ethical review committee of the University Medical Center Utrecht (protocol numbers 04/ 086, 10/359/E, and 11/072) and registered in the Netherlands Trial Register (trial numbers NL419, NL2761 and NL2680). All patients gave written informed consent.…”

Section: Patientsmentioning

confidence: 99%

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

et al. 2020

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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.

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Knee Joint Distraction as an Alternative Surgical Treatment for Osteoarthritis: Rationale and Design of two Randomized Controlled Trials (vs High Tibial Osteotomy and Total Knee Prosthesis)

Cited by 17 publications

References 38 publications

Return to Sport and Work after Randomization for Knee Distraction versus High Tibial Osteotomy: Is There a Difference?

Return to Sport and Work after Randomization for Knee Distraction versus High Tibial Osteotomy: Is There a Difference?

Five-Year Follow-up of Knee Joint Distraction: Clinical Benefit and Cartilaginous Tissue Repair in an Open Uncontrolled Prospective Study

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

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