human uncontrolled studies

 Human Open Uncontrolled Studies

  1. A new articulated distraction arthroplasty device for treatment

of the osteoarthritic knee joint: a preliminary report.

Deie M, Ochi M, Adachi N, Kajiwara R, Kanaya A.

Arthroscopy. 2007; 23(8): 833-8.

Purpose: The aim of this study was to evaluate the clinical results of a new distraction arthroplasty device when used in conjunction with a bone marrow–stimulating technique for the treatment of osteoarthritis of the knee.

Methods: We developed a new distraction arthroplasty device that allows continuous joint movement. We compared preoperative and postoperative findings for 6 knees (6 patients; age range, 42 to 58 years). The fixation period for the distraction device ranged from 7 to 13 weeks, and the follow-up period ranged from 1 to 3.5 years.

Results: The Japanese Orthopaedic Association knee score, range of motion, and joint space values were significantly improved in all cases at the latest follow-up (P < .05). Scores on a visual analogue pain scale were also significantly improved (P < .05).

Conclusions: We conclude that treatment using this new arthroplasty device in combination with a bone marrow–stimulating method was effective for osteoarthritic knees in middle-aged patients. Level of Evidence: Level IV, therapeutic case series.

  1. Arthrodiatasis for management of knee osteoarthritis.

Aly TA, Hafez K, Amin O.

Orthopedics. 2011; 34(8): e338-43.

Osteoarthritic disease is the result of mechanical and biological events that destabilize the normal processes of degradation and synthesis of articular cartilage chondrocytes, extracellular matrix, and subchondral bone. Osteoarthritis of the knee can cause symptoms ranging from mild to disabling. Initial management of most patients should be nonoperative, but because of the progressive nature of the disease, many patients with osteoarthritis of the knee eventually benefi t from operative treatment. Various procedures have been described for treatment of the osteoarthritic knee, ranging from arthroscopic lavage and debridement to total knee arthroplasty. The aim of this study was to evaluate the clinical results of distraction arthroplasty combined with arthroscopic lavage and drilling of cartilage defects for treatment of osteoarthritis of the knee. Nineteen patients (15 women and 4 men; age range, 39-65 years) were operated on. Pre- and postoperative fi ndings were compared. A control group comprising 42 patients treated with only arthroscopic procedures was evaluated for comparison. Follow- up ranged from 3 to 5 years. Results were evaluated both clinically and radiologically postoperatively and throughout the follow-up period. Clinically, pain and walking capacity improved in most patients. Radiologically, joint space widening and improvement of the tibiofemoral angle was noted in nearly all patients.

  1. Tissue structure modification in knee osteoarthritis by use of joint distraction:

an open 1-year pilot study.

Intema F, Van Roermund PM, Marijnissen AC, Cotofana S, Eckstein F, Castelein RM, Bijlsma JW, Mastbergen SC, Lafeber FP.

Annals of the Rheumeumatic Diseases. 2011; 70(8): 1441-6.

Background: Modification of joint tissue damage is challenging in late-stage osteoarthritis (OA). Few options are available for treating end-stage knee OA other than joint replacement. Objectives To examine whether joint distraction can effectively modify knee joint tissue damage and has the potential to delay prosthesis surgery.

Methods: 20 patients (<60 years) with tibiofemoral OA were treated surgically using joint distraction. Distraction (~5 mm) was applied for 2 months using an external fixation frame. Tissue structure modification at 1 year of follow-up was evaluated radiographically (joint space width (JSW)), by MRI (segmentation of cartilage morphology) and by biochemical markers of collagen type II turnover, with operators blinded to time points. Clinical improvement was evaluated by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analogue Scale (VAS) pain score.

Results: Radiography demonstrated an increase in mean and minimum JSW (2.7 to 3.6 mm and 1.0 to1.9 mm; p<0.05 and <0.01). MRI revealed an increase in cartilage thickness (2.4 to 3.0 mm; p<0.001) and a decrease of denuded bone areas (22% to 5%; p<0.001). Collagen type II levels showed a trend towards increased synthesis (+103%; p<0.06) and decreased breakdown (−11%; p<0.08). The WOMAC index increased from 45to 77 points, and VAS pain decreased from 73 to 31 mm (both p<0.001).

Conclusions: Joint distraction can induce tissue structure modification in knee OA and could result in clinical benefit. No current treatment is able to induce such changes. Larger, longer and randomised studieson joint distraction are warranted.

  1. Sustained clinical and structural benefit after joint distraction

in the treatment of severe knee osteoarthritis.

Wiegant K, van Roermund PM, Intema F, Cotofana S, Eckstein F, Mastbergen SC, Lafeber FP.

Osteoarthritis and Cartilage. 2013; 21(11): 1660-7.

Background: Treatment of severe osteoarthritis (OA) in relatively young patients is challenging. Although successful, total knee prosthesis has a limited lifespan, with the risk of revision surgery, especially in active young patients. Knee joint distraction (KJD) provides clinical benefit and tissue structure modification at 1-year follow-up. The present study evaluates whether this benefit is preserved during the second year of follow-up.

Methods: Patients included in this study presented with end-stage knee OA and an indication for total knee replacement (TKR); they were less than 60 years old with a VAS pain >60 mm (n = 20). KJD was applied for 2 months (range 54-64 days) and clinical parameters assessed using the WOMAC questionnaire and VAS pain score. Changes in cartilage structure were measured using quantitative MRI, radiography, and biochemical analyses of collagen type II turnover (ELISA).

Results: Average follow-up was 24 (range 23-25) months. Clinical improvement compared with baseline (BL) was observed at 2-year follow-up: WOMAC improved by 74% (P < 0.001) and VAS pain decreased by 61% (P < 0.001). Cartilage thickness observed by MRI (2.35 mm (95%CI, 2.06-2.65) at BL) was significantly greater at 2-year follow-up (2.78 mm (2.50-3.09); P < 0.03). Radiographic minimum joint space width(JSW) (1.1 mm (0.5 -1.7) at BL) was significantly increased at 2-year follow-up as well (1.7 mm (1.1-2.3); P < 0.03). The denuded area of subchondral bone visualized by MRI (22% (95%CI, 12.5-31.5) at BL) was

significantly decreased at 2-year follow-up (8% (3.6-12.2); P < 0.004). The ratio of collagen type II synthesis

over breakdown was increased at 2-year follow-up (P < 0.07).

Conclusion: Clinical improvement by KJD treatment is sustained for at least 2 years. Cartilage repair is still present after 2 years (MRI) and the newly formed tissue continues to be mechanically resilient as shown by an increased JSW under weight-bearing conditions.

  1. Five-year follow-up of knee joint distraction; clinical benefit and

cartilaginous tissue repair in an open uncontrolled prospective study.

Van der Woude JAD, Wiegant K, van Roermund PM, Intema F, Custers RJH, RM, Eckstein F, van Laar JM, Mastbergen SC, Lafeber FPJG.

Cartilage. 2017. July; 8 (3): 263-271

Introduction: Osteoarthritis (OA) often affects the tibio-femoral joint, resulting in persistent pain, progressive cartilage damage, and impaired function. Although a total knee prosthesis (TKP) 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 five-year follow-up data of KJD.

Methods: Patients (n=20; <60yrs) with conservative therapy resistant tibio-femoral OA were treated. Clinical evaluation was performed by WOMAC and VAS-pain scores. Changes in cartilage thickness were quantified by radiographs and MRI. The five-year changes after KJD were evaluated and compared with the natural progression of OA in OsteoArthritis-Initiative participants with similar baseline characteristics.

Results: Two patients withdrew informed consent and three other patients were treated with TKP (after three and four years). In these cases the last measures werecarried forward. Five years after treatment patients reported clinical improvementfrom baseline: Δ WOMAC +21,1 points (95%CI +8,9-+33,3; p=0.002), Δ VAS pain -27,6mm (95%CI -13,3--42,0; p<0.001). Minimum radiographic joint-space-width(JSW) was increased at five years as compared to pre-treatment values: Δ+0,43mm(95%CI +0,02-+0,84; p=0.040). Mean JSW on radiographs and mean cartilagethickness on MRI, of the most affected compartment (medial/lateral: 18/2), were after their initial statistically significant increase not statistically different frombaseline anymore (Δ+0,26mm; p=0.370, and Δ+0,23mm; p=0.177, respectively). Taking natural loss of cartilage thickness into account, this change was significantlydifferent from the changes as a result of estimated natural progression (Δ-0,39mmand Δ-0,18mm, respectively) resulting at five years in a difference of +0,65mm (95%CI +0,07-+1,23; p=0.031) and of +0,41mm (95%CI +0,07-+0,74; p=0.020) forradiographic mean JSW and average cartilage thickness on MRI, respectively.

Conclusion: 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 of tissue loss. KJD therefore represents a promising therapeutic option for young patients.

  1. Initial tissue repair predicts long-term clinical success of knee joint distraction as treatment for knee osteoarthritis-year follow-up of knee joint distraction; clinical benefit and

cartilaginous tissue repair in an open uncontrolled prospective study.

Jansen MP, van der Weiden GS, Van Roermund PM, Custers RJH, Mastbergen SC, Lafeber FPJG.

Osteoarthritis Cartilage. 2018 Dec;26(12):1604-1608.

OBJECTIVE: Knee joint distraction (KJD), a joint-preserving surgery for severe osteoarthritis (OA), provides clinical and structural improvement and postpones the need for total knee arthroplasty (TKA). This study evaluates 9-year treatment outcome and identifies characteristics predicting long-term treatment success.

DESIGN: Patients with severe tibiofemoral OA (n = 20; age<60 years) indicated for TKA were treated with KJD. Questionnaires, radiographs, and magnetic resonance imaging (MRI) were used for evaluation. Survival after treatment was analyzed, where 'failure' was defined by TKA over time.

RESULTS: 9-year survival was 48%, and 72% for men (compared to 14% for women; P = 0.035) and 73% for those with a first-year minimum joint space width (JSW) increase of >0.5 mm (compared to 0% for <0.05 mm; P = 0.002). Survivors still reported clinical improvement compared to baseline (ΔWOMAC +29.9 points (95%CI 16.9-42.9; P = 0.001), ΔVAS -46.8 mm (-31.6-61.9; P < 0.001)). Surprisingly, patients getting TKA years after KJD still reported clinical improvement although less pronounced (ΔWOMAC +20.5 points (-1.8-42.8; P = 0.067), ΔVAS -25.4 mm (-3.2-47.7; P = 0.030)). Survivors showed long-lasting minimum JSW increase (baseline 0.3 mm (IQR 1.9), follow-up 1.3 mm (2.5); P = 0.017) while 'failures' did not (baseline 0.4 mm (1.8), follow-up 0.2 mm (1.5); P = 0.161). First-year minimum JSW on radiographs and cartilage thickness increase on MRI predict 9-year survival (HR 0.05 and 0.12, respectively; both P < 0.026). Male gender was associated with survival (HR 0.24; P = 0.050).

CONCLUSIONS: KJD shows long-lasting clinical and structural improvement. In addition to a greater survival rate for males (>two out of three), the initial cartilage repair activity appears to be important for long-term clinical success.