Evaluating the use of intra-articular injections as a treatment for painful hip osteoarthritis: a randomized, double-blind, multicenter, parallel-group study comparing a single 6-mL injection of hylan G-F 20 with saline.
Brander V,Skrepnik N,Petrella R J,Jiang G-L,Accomando B,Vardanyan A
Osteoarthritis and cartilage
OBJECTIVE:Hip osteoarthritis (OA) is difficult to treat. Steroid injections reduce pain with short duration. With widespread adoption of office-based, image-guided injections, hyaluronic acid is a potentially relevant therapy. In the largest clinical trial to-date, we compared safety/efficacy of a single, 6-mL image-guided injection of hylan G-F 20 to saline in painful hip OA. METHOD:357 patients were enrolled in a multicenter, double-blind, randomized saline placebo- controlled trial. Subjects were ≥35 years of age, with painful (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]-A1:5.0-8.0; numeric rating scale [NRS]: 0-10) mild-to-moderate hip OA (Kellgren-Lawrence grade II/III) and minimal contralateral hip pain (WOMAC-A1 < 4). Outcome measures included "pain on walking" (WOMAC-A1 and -A), Patient Global Self-Assessment (PTGA), WOMAC-A1 responder rate (+≥2 points on NRS), and adverse events (AEs) over 26 weeks. RESULTS:357 patients (hylan G-F 20 single:182; saline:175) were enrolled. Both groups demonstrated significant pain improvement from baseline over 26 weeks (P < 0.0001); saline-induced pain reduction was a remarkable 35%. WOMAC-A and PTGA scores also significantly improved (P < 0.0001). No statistically significant difference was observed between groups in WOMAC-A1 scores (hylan G-F 20 single:-2.19 ± 0.16; saline:-2.26 ± 0.17) or WOMAC-A1 responders (41-52%). Treatment-related AE rates at target hip were similar (hylan G-F 20 single:23 patients [12.8%]; saline:12 [7.0%]). Posthoc analysis found, despite protocol requirements, many patients had psychological (31%) or potential neuropathic pain (27.5%) conditions. CONCLUSION:A single 6-mL hylan G-F 20 injection or saline for painful hip OA resulted in similar, statistically significant/clinically relevant pain and function improvements up to 6 months following injection; no differences between hylan G-F 20 and saline placebo were observed.
Bone autografting in medial open wedge high tibial osteotomy results in improved osseous gap healing on computed tomography, but no functional advantage: a prospective, randomised, controlled trial.
Fucentese Sandro F,Tscholl Philippe M,Sutter Reto,Brucker Peter U,Meyer Dominik C,Koch Peter P
Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
PURPOSE:Medial open wedge high tibial osteotomy (owHTO) is a valuable surgical technique used to manage medial degeneration in varus knees. Iliac crest autograft is considered the gold standard gap-filler. It was hypothesised that iliac crest autograft promotes gap healing and improves functional outcome in owHTO. METHODS:Between 2005 and 2009, patients scheduled to undergo owHTO stabilised by a medial locking compression plate were randomised to undergo owHTO either with iliac crest autograft (group A) or without bone void filler (group B). Pre- and postoperative leg axes were recorded. At 3 and 12 months postoperatively, the healing of the osteotomy gap was measured as a percentage on CT images, and functional scores were recorded. RESULTS:There were 15 patients in group A, and 25 in group B. The groups were similar in age, sex ratio, knee varus deformity, body mass index, and smoking status. Group A and B had similar preoperative varus (6.9° vs. 7.6°) and postoperative valgus (2.2° vs. 3.0°). Compared with the control group, group A had a significantly greater degree of osseous gap healing after 3 months (40.1% vs. 10.8%, p = 0.045) and 12 months (91.5% vs. 59.1%, p ≤ 0.001). Multiple linear regression analysis found that bone grafting was an independent promoting factor for gap healing, while increased preoperative varus was an independent retardant factor at 3 months (p = 0.004 and p = 0.002, respectively) and 12 months (p ≤ 0.001 and p = 0.003, respectively). Younger age was a promoting factor for gap healing on CT at 3 months (p ≤ 0.001), but not at 12 months. No correlations were found between bone healing and functional outcome, body mass index, or smoking status. CONCLUSIONS:Iliac crest autograft significantly increases healing of the osteotomy gap after owHTO. Increased preoperative varus and older patient age are independent factors that delay early healing of the osteotomy. However, no functional advantage was found at 3 or 12 months postoperatively. Therefore, routine use of iliac crest autograft cannot be recommended. LEVEL OF EVIDENCE:II.
Implantation of mesenchymal stem cells in combination with allogenic cartilage improves cartilage regeneration and clinical outcomes in patients with concomitant high tibial osteotomy.
Kim Yong Sang,Chung Pill Ku,Suh Dong Suk,Heo Dong Beom,Tak Dae Hyun,Koh Yong Gon
Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
PURPOSE:This study aimed to compare the clinical, radiological, and second-look arthroscopic outcomes of implanting mesenchymal stem cells (MSCs) alone and together with allogenic cartilage in patients treated with concomitant high tibial oteotomy (HTO) for varus knee osteoarthritis. METHODS:Eighty patients treated with cartilage repair procedures and concomitant HTO were prospectively randomized into two groups: MSC implantation (MSC group), and MSC implantation with allogenic cartilage (MSC-AC group). Clinical outcomes were evaluated using the Lysholm Score and the Knee Injury and Osteoarthritis Outcome Score (KOOS) at preoperative and every follow-up visit. Radiological outcomes were evaluated by measuring the femorotibial angle and posterior tibial slope. During second-look arthroscopy, cartilage regeneration was evaluated according to the Kanamiya grade. RESULTS:Clinical outcomes at the second-look arthroscopy (mean 12.5 months [MSC group] and 12.4 months [MSC-AC group]) improved significantly in both groups (P < 0.001 for all). Clinical outcomes from the second-look arthroscopy to the final follow-up (mean 27.3 months [MSC group] and 27.8 months [MSC-AC group]) improved further only in the MSC-AC group (P < 0.05 for all). Overall, the Kanamiya grades, which were significantly correlated with clinical outcomes, were significantly higher in the MSC-AC group than in the MSC group. Radiological outcomes at final follow-up revealed improved knee joint alignments relative to preoperative conditions but without significant correlation between clinical outcomes and Kanamiya grade in either group (n.s. for all). CONCLUSION:Implantation of MSCs with allogenic cartilage is superior to implantation of MSCs alone in cartilage regeneration accompanied with better clinical outcomes. LEVEL OF EVIDENCE:Therapeutic study, level II.
Lower Limb Length Discrepancy After High Tibial Osteotomy: Prospective Randomized Controlled Trial of Lateral Closing Versus Medial Opening Wedge Osteotomy.
Kim Joong Il,Kim Bo Hyun,Lee Ki Woung,Lee Osung,Han Hyuk Soo,Lee Sahnghoon,Lee Myung Chul
The American journal of sports medicine
BACKGROUND:High tibial osteotomy (HTO) produces valgus limb alignment, and this change can affect lower limb length. PURPOSE:To compare the change in lower limb length and the discrepancy compared with the contralateral limb after unilateral lateral closing wedge HTO (CWHTO) and medial opening wedge HTO (OWHTO). STUDY DESIGN:Randomized controlled trial; Level of evidence, 1. METHODS:In this study, 30 knees undergoing unilateral CWHTO and 30 knees undergoing unilateral OWHTO for medial compartmental osteoarthritis were analyzed with 1-year follow-up. The tibial length, lower limb length, and lower limb length discrepancy were measured preoperatively and 1 year postoperatively. The patients' subjective sensation of, and discomfort due to, the lower limb length discrepancy were recorded 1 year postoperatively. Univariate and multivariate linear regression analyses were conducted to identify predictors related to the change in lower limb length. RESULTS:The mean lengths of the tibia and lower limb increased significantly after OWHTO (5.2 ± 3.7 and 7.6 ± 2.1 mm, respectively; P < .001). The mean tibial length decreased significantly after CWHTO (-6.0 ± 2.1 mm; P < .001); however, the mean lower limb length change was not significant (-0.8 ± 2.5 mm; P = .073). The mean lower limb length discrepancy increased significantly after OWHTO (-0.5 ± 0.7 to 7.2 ± 2.1 mm; P < .001) but not after CWHTO (-0.7 ± 0.6 to -1.0 ± 2.5 mm; P = .539). A significantly greater proportion of patients in the OWHTO group were aware of (70% vs 20%, respectively; P = .002), and uncomfortable because of (37% vs 7%, respectively; P = .010), the lower limb length discrepancy compared with those in the CWHTO group. The strongest predictor of a change in lower limb length was the wedge length in the OWHTO group and the preoperative hip-knee-ankle angle in the CWHTO group. CONCLUSION:The lower limb length change and discrepancy were significant after unilateral OWHTO, whereas they were negligible after unilateral CWHTO. CWHTO was more beneficial in cases of unilateral HTO to minimize the discrepancy of lower limb length rather than OWHTO, particularly in knees requiring a large correction. REGISTRATION:Clinical Trials Registry Platform (protocol number KCT00001684).
Comparison of HTO with articular cartilage surgery and UKA in unicompartmental OA.
Jeon Yoon Sang,Ahn Chi Hoon,Kim Myung-Ku
Journal of orthopaedic surgery (Hong Kong)
PURPOSE:The purpose of this article was to assess the clinical outcome of high tibial osteotomy (HTO) with articular cartilage surgery compared with unicompartmental knee arthroplasty (UKA) in unicompartmental osteoarthritis (OA). METHODS:We designed retrospective study and evaluated 47 patients with unicompartmental OA (Kellgren-Laurence [K-L] grade ≥III OA). Two groups of patients underwent either HTO with articular cartilage surgery or UKA by the senior author between January 2010 and April 2013. The minimum follow-up period is 2 years. Clinical outcomes were assessed using Knee Injury and Osteoarthritis Outcome Scores, International Knee Documentation Committee (IKDC), and visual analog scale (VAS) score. And we evaluated the radiologic result of HTO and UKA by measuring mechanical axis at preoperative period and at last follow-up. RESULTS:The IKDC score was significantly better in the UKA group than in the HTO group at 6 months but there was no significant difference in the two groups at 2 years. The VAS score was improved at the final follow-up compared to before surgery in both groups and did not show significant intergroup difference ( p = 0.123). There was no significant difference in the preoperative mechanical axis in the two groups. But their mechanical axis at the final follow-up were significantly different ( p = 0.0001). CONCLUSION:The clinical outcome was significantly better in the UKA group at 6 months. But in the two groups, there were no significant differences at 12 months and 2-year follow-up, and the mechanical axis correction effect is greater than the UKA group. Based on our research, HTO with articular cartilage surgery can be considered as the treatment of choice for more active and younger patients with unicompartmental OA.
Is a high tibial osteotomy (HTO) superior to non-surgical treatment in patients with varus malaligned medial knee osteoarthritis (OA)? A propensity matched study using 2 randomized controlled trial (RCT) datasets.
van Outeren M V,Waarsing J H,Brouwer R W,Verhaar J A N,Reijman M,Bierma-Zeinstra S M A
Osteoarthritis and cartilage
OBJECTIVE:No randomized controlled trial (RCT) has compared the high tibial osteotomy (HTO) with non-surgical treatment in patients with medial knee osteoarthritis (OA) and varus malalignment. The aim was to compare the effectiveness of an unloader brace treatment or a usual care program to the HTO regarding pain severity and knee function. DESIGN:Surgical treatment (HTO) to two non-surgical options was compared by combining the data of two RCTs. One RCT (n = 117) compared an unloader brace to usual care treatment; the other RCT (n = 92) compared closing to opening wedge HTO. One-to-many propensity score matching was used to equalize patient characteristics. We compared clinical outcome at 1 year follow-up (VAS pain (0-10) and knee function (HSS, 0-100)) with mixed model analysis. RESULTS:Propensity score matching resulted in a comparison of 30 brace patient with 83 HTO patients, and of 28 usual care patients with 71 HTO patients. Pain at 1 year after HTO (VAS 3.8) was lower than after valgus bracing (VAS 5.0) with a mean difference of -1.1 (95% CI -2.2; -0.1). Function showed a nonsignificant mean difference of 2.1 [95% CI -3.1; 7.3]. Comparing HTO to usual care a difference was seen in pain (-1.7 [95% CI -2.8; -0.6]) and function (6.6 [95% CI 0.2; 13.1]), in favor of the HTO. CONCLUSIONS:Our data suggest that HTO was more effective in pain reduction compared to both non-surgical treatments. Function improved only when HTO was compared to usual care treatment. These small differences question the benefits of surgical treatment over the brace treatment.