human controlled studies

 Human controlled Studies

  1. Knee joint distraction as an alternative surgical procedure for patients

with osteoarthritis considered for high tibial osteotomy

or for a total knee prosthesis: rationale and design of two randomized controlled trials.

Wiegant K, van Heerwaarden RJ, van der Woude JAD, Custers RJH, Emans PJ, Kuchuk NO, Mastbergen SC, Lafeber FPJG.

International Journal of Orthopaedics. 2015; 2(3): 155-1592).

Aim: In case of refractory knee osteoarthritis at a relatively young age causing persisting pain, treatment options are limited. In case of medial degeneration high tibial osteotomy (HTO) may be considered, or in case of more generalized OA, a total knee prosthesis (TKP). However, these young and active patients have a major risk of revision surgery. Knee joint distraction (KJD) could be an alternative treatment; prolonged clinical benefit and cartilage tissue repair have been demonstrated. Therefore, two RCTs were designed, evaluating clinical efficacy and for HTO additionally comparing cartilage tissue repair.

Materials and methods: Patients<65 years of age considered in regular clinical practice for TKP or HTO were included. TKP and HTO were performed according to usual standard of care. KJD was performed for six continuous weeks by use of an external fixator bridging the joint, fixed at each side to two bone pins.

Results: Inclusion rate was stable over time and took 42 and 22 months for TKP vs KJD and HTO vs KJD, respectively. At baseline, patient characteristics differed: age was 55.2±0.9 and 50.0±0.7 p<0.000, KOOS-score was 36.6±1.4 and 42.2±1.6 p=0.012, and VAS-pain was 68.7±2.1 and 61.4±2.4 p=0.028, in the KJD-TKP cohort and KJD-HTO cohort, respectively.

Conclusion: For implementation of KJD a comparison with available surgical alternatives is needed. TKP and HTO were chosen as the most relevant comparators. Inclusion is closed, and all treatments are completed. Data have to be awaited to determine the position of KJD in surgical treatment of refractory knee OA.A new articulated distraction arthroplasty device for treatment

of the osteoarthritic knee joint: a preliminary report.

  1. Knee joint distraction compared with high tibial osteotomy: a randomized controlled trial.

van der Woude JAD, Wiegant K, van Heerwaarden RJ, Spruijt S, van Roermund PM, Custers RJH, Mastbergen SC, Lafeber FPJG.

Knee Surgery, Sports Traumatology, Arthroscopy. 2017 Mar;25(3):876-886.

Purpose: Both, knee joint distraction as a relatively new approach and valgus-producing opening-wedge high tibial osteotomy (HTO), are knee-preserving treatments for knee osteoarthritis (OA). The efficacy of knee joint distraction compared to HTO has not been reported.

Methods: Sixty-nine patients with medial knee joint OA with a varus axis deviation of <10° were randomized to either knee joint distraction (n = 23) or HTO (n = 46). Questionnaires were assessed at baseline and 3, 6, and 12 months. Joint space width (JSW) as a surrogate measure for cartilage thickness was determined on standardized semi-flexed radiographs at baseline and 1-year follow-up.

Results: All patient-reported outcome measures (PROMS) improved significantly over 1 year (at 1 year p < 0.02) in both groups. At 1 year, the HTO group showed slightly greater improvement in 4 of the 16PROMS (p < 0.05). The minimum medial compartment JSW increased 0.8 ± 1.0 mm in the knee joint distraction group (p = 0.001) and 0.4 ± 0.5 mm in the HTO group (p < 0.001), with minimum JSW improvement in favour of knee joint distraction (p = 0.05). The lateral compartment showed a small increase in the knee joint distraction group and a small decrease in the HTO group, leading to a significant increase in mean JSW for knee joint distraction only(p < 0.02).

Conclusion: Cartilaginous repair activity, as indicated by JSW, and clinical outcome improvement occurred with both, knee joint distraction and HTO. These findings suggest that knee joint distraction may be an alternative therapy for medial compartmental OA with a limited mechanical leg malalignment. Level of evidence Randomized controlled trial, Level I.

  1. Knee joint distraction compared with total knee arthroplasty:

a randomized controlled trial.

van der Woude JAD, Wiegant K, van Heerwaarden RJ, Spruijt S, van Roermund PM, Mastbergen SC, Lafeber FPJG.

The Bone & Joint Journal. 2017 Jan;99-B(1):51-58

Aims: Knee joint distraction (KJD) is a relatively new, knee-joint preserving procedure with the goal to postpone a first total knee arthroplasty (TKA) in specifically young and middle-aged patients, to decrease the chance for revision surgery later in life. However, the clinical efficacy of KJD has never been compared to TKA.

Patients and Methods: Sixty patients ≤ 65 years with end-stage knee osteoarthritis were randomized to either KJD (n=20) or TKA (n=40). Questionnaires were assessed at baseline, three, six, nine, and twelve months. In the KJD-group, radiographic joint space width (JSW), representing cartilage thickness, was determined as well.

Results:  Fifty-six patients received the allocated intervention (TKA=36, KJD=20). All patient reported outcome measures improved significantly over one year (at one year p<0.02) in both groups. At one year, the TKA-group showed a greater improvement in only 1 out of the 16 PROMS assessed (p<0.05). OARSI-OMERACT clinical response was 83% after TKA and 80% after KJD. Twelve patients (60%) in the KJD-group suffered from pin tract infections. In the KJD-group both minimum (+0.9±1.1mm,) and mean JSW (+1.2±1.1mm) increased significantly (p<0.01).

Conclusions: In relatively young patients with end-stage knee osteoarthritis treatment with KJD did not demonstrate relevant inferiority in efficacy compared to TKA.Arthrodiatasis for management of knee osteoarthritis.

  1. Knee Joint Distraction Compared with High Tibial Osteotomy and Total Knee Arthroplasty: Two-Year Clinical, Radiographic, and Biochemical Marker Outcomes of Two Randomized Controlled Trials.

Jansen MP, Besselink NJ, van Heerwaarden RJ, Custers RJH, Emans PJ, Spruijt S, Mastbergen SC, Lafeber FPJG.

Cartilage. 2019 Feb 13:1947603519828432. doi: 10.1177/1947603519828432. [Epub ahead of print]

OBJECTIVE: Both, knee joint distraction (KJD) and high tibial osteotomy (HTO) are joint-preserving surgeries that postpone total knee arthroplasty (TKA) in younger osteoarthritis (OA) patients. Here we evaluate the 2-year follow-up of KJD versus TKA and KJD versus HTO in 2 noninferiority studies.

DESIGN: Knee OA patients indicated for TKA were randomized to KJD ( n = 20; KJDTKA) or TKA ( n = 40). Medial compartmental knee OA patients considered for HTO were randomized to KJD ( n = 23; KJDHTO) or HTO ( n = 46). Patient-reported outcome measures were assessed over 2 years of follow-up. The radiographic joint space width (JSW) was measured yearly. In the KJD groups, serum-PIIANP and urinary-CTXII levels were measured as collagen type-II synthesis and breakdown markers. It was hypothesized that there was no clinically important difference in the primary outcome, the total WOMAC, when comparing KJD with HTO and with TKA.

RESULTS: Both trials were completed, with 114 patients (19 KJDTKA; 34 TKA; 20 KJDHTO; 41 HTO) available for 2-year analyses. At 2 years, the total WOMAC score (KJDTKA: +38.9 [95%CI 28.8-48.9] points; TKA: +42.1 [34.5-49.7]; KJDHTO: +26.8 [17.1-36.6]; HTO: +34.4 [28.0-40.7]; all: P < 0.05) and radiographic minimum JSW (KJDTKA: +0.9 [0.2-1.6] mm; KJDHTO: +0.9 [0.5-1.4]; HTO: +0.6 [0.3-0.9]; all: P < 0.05) were still increased for all groups. The net collagen type-II synthesis 2 years after KJD was increased ( P < 0.05). Half of KJD patients experienced pin tract infections, successfully treated with oral antibiotics.

CONCLUSIONS: Sustained improvement of clinical benefit and (hyaline) cartilage thickness increase after KJD is demonstrated. KJD was clinically noninferior to HTO and TKA in the primary outcome.