Knee Joint Distraction Compared with Total Knee Arthroplasty a RANDOMISED CONTROLLED TRIAL

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Knee Joint Distraction Compared with Total Knee Arthroplasty a RANDOMISED CONTROLLED TRIAL KNEE Knee joint distraction compared with total knee arthroplasty A RANDOMISED CONTROLLED TRIAL J. A. D. van der Woude, Aims K. Wiegant, Knee joint distraction (KJD) is a relatively new, knee-joint preserving procedure with the R. J. van Heerwaarden, goal of delaying total knee arthroplasty (TKA) in young and middle-aged patients. We S. Spruijt, present a randomised controlled trial comparing the two. P. J. E m ans , Patients and Methods S. C. Mastbergen, The 60 patients ≤ 65 years with end-stage knee osteoarthritis were randomised to either F. P. J. G. Lafeber KJD (n = 20) or TKA (n = 40). Outcomes were assessed at baseline, three, six, nine, and 12 months. In the KJD group, the joint space width (JSW) was radiologically assessed, From UMC Utrecht, representing a surrogate marker of cartilage thickness. Utrecht, The Netherlands Results In total 56 patients completed their allocated treatment (TKA = 36, KJD = 20). All patient reported outcome measures improved significantly over one year (p < 0.02) in both groups. J. A. D. van der Woude, MD, At one year, the TKA group showed a greater improvement in only one of the 16 patient- PhD, Resident in Orthopaedic Surgery, Limb and Knee related outcome measures assessed (p = 0.034). Outcome Measures in Rheumatology- Reconstruction Unit, Department of Orthopaedic Osteoarthritis Research Society International clinical response was 83% after TKA and 80% Surgery after KJD. A total of 12 patients (60%) in the KJD group sustained pin track infections. In the R. J. van Heerwaarden, MD, PhD, Orthopaedic Surgeon, KJD group both mean minimum (0.9 mm, standard deviation (SD) 1.1) and mean JSW (1.2 mm, Limb and Knee Reconstruction Unit, Department of SD 1.1) increased significantly (p = 0.004 and p = 0.0003). Orthopaedic Surgery S. Spruijt, MD, Orthopaedic Conclusion Surgeon, Limb and Knee Reconstruction Unit, In relatively young patients with end-stage knee osteoarthritis, KJD did not demonstrate Department of Orthopaedic inferiority of outcomes at one year when compared with TKA. However, there is a high Surgery Maartenskliniek Woerden, incidence of pin track infection associated with KJD. Woerden, The Netherlands. K. Wiegant, MD, PhD, Cite this article: Bone Joint J 2017;99-B:51–8. Resident in Orthopaedic Surgery, Rheumatology and In end-stage osteoarthritis (OA) of the knee a TKAs performed in patients aged under 65 Clinical Immunology total knee arthroplasty (TKA) is generally indi- years, a burden of revision arthroplasty may S. C. Mastbergen, PhD, 1 9-10 Associate Professor, cated. This intervention for OA was first per- well be generated. Rheumatology and Clinical Immunology formed in the 1970s and is now generally On this basis, joint-preserving surgery is an F. P. J. G. Lafeber, PhD, regarded as standard treatment.1,2 However, attractive option, but arthroscopic debride- Professor of Experimental Rheumatology, Rheumatology joint arthroplasty is not without drawbacks, ment, one of the most popular forms, is and Clinical Immunology, UMC Utrecht, Utrecht, The with up to 20% of patients dissatisfied with becoming less supported by modern evi- Netherlands. their TKA and up to 44% reporting continuing dence.11,12 Osteotomies have a place in uni- P. J. Emans, MD, PhD, pain, a third of whom reported extreme persis- compartmental disease and the KineSpring Orthopaedic Surgeon, 3-6 Department of Orthopaedics tent pain in one study. Patients younger than (Moximed Inc., Hayward, California) has MUMC Maastricht, Maastricht, The Netherlands. 55 years have an almost fivefold increase in the recently been introduced for medial compart- lifetime risk of revision surgery compared with ment disease, although long-term evidence of Correspondence should be sent 7 13,14 to F. P. J. G. Lafeber; email: those aged 75 years or older. One of the main its efficacy is yet to become available. [email protected] reasons for this is aseptic loosening, a charac- Knee joint distraction (KJD) has been pro- ©2017 The British Editorial teristic of implant wear, which is responsible posed as a temporising technique for sympto- Society of Bone & Joint 7,8 Surgery for more than 30% of revisions. Since wear matic, arthritic knees in younger patients and doi:10.1302/0301-620X.99B1. increases with both time and activity, a young comprises a six- to eight-week period of dis- BJJ-2016-0099.R3 $2.00 patient with relatively higher functional traction of the knee by means of an external Bone Joint J demands of the implant can experience signifi- fixator. A prospective, uncontrolled study of 2017;99-B:51–8. Received 17 March 2016; cantly more wear than their older, more seden- 20 patients aged below 60 years at five-year Accepted after revision 13 September 2016 tary counterparts. In addition, with 40% of follow-up reported clinical improvement and VOL. 99-B, No. 1, JANUARY 2017 51 52 J. A. D. VAN DER WOUDE, K. WIEGANT, R. J. VAN HEERWAARDEN, S. SPRUIJT, P. J. EMANS, S. C. MASTBERGEN, F. P. J. G. LAFEBER All surgery was performed by one of three surgeons (RJvH, SS or PJE). Knee arthroplasty was performed using the Genesis II posterior stabilised system (Smith & Nephew, Warsaw, Indiana) with fixation using GentaPala- cos cement (Heraeus, Hanau, Germany). Routine post- operative rehabilitation and venous thrombo-embolism prophylaxis was provided. Distraction surgery was per- formed using the Triax proof-of-concept external distrac- tion device (Stryker, Kalamazoo, Michigan), based around two tubes with internal 45 kg springs (Fig. 1). Eight fixa- tion pins were used to provide two points of fixation for each tube, each side of the knee. The knee was distracted by 2 mm intra-operatively and distracted a further 1 mm during the following three days, achieving total distraction of 5 mm. This was verified radiologically on post-operative Fig. 1 day four and patients were then discharged on crutches. Ini- tially patients were permitted to transmit up to 20% body Example of the bilateral external fixation frame used for knee joint dis- traction treatment (left) and an example of a radiograph (right) during weight through the operated limb, which increased to full distraction treatment with 5 mm of distraction. weight bearing within six weeks. Radiological evaluation of the distraction and clinical assessment of the pin sites evidence of cartilage repair. If these results were to be gen- was made at three weeks post-operatively in the outpatient erally applicable, the possibility arises of delaying the clinic. The fixator was removed at six weeks. Patients were requirement of TKA in young patients.15-18 prescribed low molecular weight heparin for the duration This study is a randomised controlled trial comparing of fixation and for three weeks thereafter. outcomes of KJD with TKA at one year. A total of 60 patients were recruited to the study, with four withdrawing consent once randomised to TKA, leav- Patients and Methods ing a population of 56 patients (Fig. 2). The demographic This study was conducted in two centres between 2011 and characteristics of the participants are given in Table I.22 2014. Randomisation was conducted in a 2:1 ratio in favour Initial baseline scores were taken at randomisation, and of TKA in blocks of six by a sealed envelope method. The again the day before surgery. Questionnaires were further ratio was a condition of the institutional review board’s completed at three, six, nine and 12 months post- favourable opinion. Group size calculation was based on a operatively. non-inferiority hypothesis. The sample size was based on The WOMAC and knee injury and osteoarthritis out- non-inferiority in the primary outcome measure, the Western come score (KOOS)23 were used to score clinical improve- Ontario and McMaster Universities Osteoarthritis Index ment, normalised to a 100-point scale with 100 being the (WOMAC),19 with a 5% type I error, and with a power of best condition possible. The intermittent and constant 80%.20 A 15% margin was allowed for loss to follow-up. A osteoarthritis pain score (ICOAP)24 for the knee was the difference in WOMAC score of more than 15 points (stand- secondary clinical outcome parameter (0 to 100, 0 repre- ard deviation (SD) 16.7) compared with the TKA group was senting no pain). A visual analogue scale for pain (VAS- considered clinically relevant.21 This resulted in group sizes pain; 0 mm to 100 mm, 0 representing no pain and 100 of 40 patients for TKA and 20 for KJD. Neither patient nor severe pain) was the tertiary clinical outcome parameter. surgeon was blinded to treatment. The EuroQol (EQ)-5D-3L25 was used to assess improve- Inclusion criteria were OA of the knee and eligibility for ment of quality of life. The obtained questionnaire was TKA according to routine standard of care, age ≤ 65 years, transformed to an EQ-5D index score (0 to 1, 1 being best). functionally intact knee ligaments, ≥ 120° flexion at the The Short Form (SF)-36 health survey26 was used to meas- knee and body mass index (BMI) < 35 kg/m2. Patients with ure the health status of the patients. The SF-36 items were primary patellofemoral OA were excluded, as were those converted to physical (PCS) and mental (MCS) component with a history of inflammatory or septic arthritis, inability summary scores. At baseline, three, six, nine and 12 months to tolerate external fixation, an already ankylosed knee, the KOOS/WOMAC, ICOAP, EQ-5D-3L and VAS-pain post-traumatic fibrosis due to a fracture of the tibial pla- were recorded. At baseline, six, and 12 months the SF-36 teau, previous surgery on the same knee within the past six was recorded. months, or previous joint arthroplasties. The study was Radiographs of the KJD group were obtained at baseline granted ethical approval (No 10/359/E) and was registered and 12 months post-operatively.
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