Efficacy and Safety of Intra-articular Sodium Hyaluronate for Ankle-involved Kashin-Beck Disease: A 12-month Prospective Self-controlled Study

Summary

This article presents a 12-month prospective study evaluating the efficacy and safety of intra-articular sodium hyaluronate injections for ankle-involved Kashin-Beck disease (KBD). Results indicate that this treatment significantly reduces pain and improves joint function and quality of life.

Abstract

This study aimed to evaluate the efficacy and safety of intra-articular sodium hyaluronate injection over a 12-month follow-up period in patients with ankle-involved Kashin-Beck Disease (KBD).

A 12-month, prospective, self-controlled study was carried out among 79 adult patients with ankle-involved KBD. Each patient was given three consecutive weekly intra-articular injections of sodium hyaluronate (2 mL, 20 mg) in the affected ankle joint. The Graded Chronic Pain Scale (GCPS) was used to evaluate pain intensity, the KBD Joint Dysfunction Index (JDI) was used to assess joint function, and the EQ-5D-3L was used to assess quality of life (QoL). These three outcome measures were assessed at baseline (prior to the first injection), Week 4 (one week after the third injection), and Month 12 (12 months after the first injection). Longitudinal changes were analyzed using Generalized Estimating Equations (GEE).

Over the 12 months, all the ankle outcomes significantly improved compared with baseline (all p < 0.001). The estimated marginal means (EMM) of GCPS pain score decreased from 67.24 to 30.56. The JDI scores decreased from 7.31 to 3.64, and the EQ-5D-3L utility index increased from 0.707 to 0.869. Significant time × KBD stage interactions were found in ankle pain (Wald χ²= 15.82, p = 0.003) and EQ-5D-3L utility index (Wald χ²= 37.25^, p < 0.001). While patients with Stage III appeared to have the most significant improvements, these subgroup findings should be considered exploratory due to the limited sample size. Only 3.46% of patients reported adverse events, which were mild and transient.

In conclusion, intra-articular sodium hyaluronate injection provides significant and sustained pain relief, functional recovery, and QoL improvement for patients with ankle-involved KBD. It is a safe and effective conservative treatment strategy.

Introduction

Kashin-Beck disease (KBD) is an endemic, disabling osteoarthropathy of unknown etiology, mainly occurring in children during growth and development. Its geographic distribution takes a belt-like pattern from northeast to southwest China^1,2,3. The main pathological change of KBD is multifocal symmetric degeneration and necrosis of articular and epiphyseal plate cartilage, followed by severe sequelae, such as joint pain, joint deformity, functional impairment, and short stature^4,5. After the comprehensive preventive and....

Protocol

This study was performed according to the Declaration of Helsinki and approved by the Ethics Committee of Xi'an Jiaotong University (Approval No: 2016106). All participants signed informed consent before enrollment in the study procedures. According to the protocol approved by the ethics committee, a 2-week washout period was provided to minimize the confounding effect of previous medication use.

Study design and setting

This was a prospective, self-controlled study conducted in Yongshou and Linyou Counties, Shaanxi Province, where the reported prevalence rate of KBD is among the highest in China

Results

Baseline characteristics of study participants

A total of 79 patients with KBD involving the ankle were enrolled in this prospective study. All of them were farmers. The mean age of participants was 60.07 ± 6.83 years, and 54.43% were male. According to the KBD radiological classification, most patients were in Stage I (n = 47, 59.49 %), followed by Stage II (n = 24, 30.38 %) and Stage III (n = 8, 10.13%). At baseline, no significant differences were found among the stages in .......

Discussion

This prospective self-controlled study provides important preliminary evidence of the efficacy and safety of intra-articular sodium hyaluronate in the ankle involvement of KBD. The experimental protocol was feasible and effective using a standard regimen of three weekly intra-articular injections¹⁴. Over a 12-month follow-up, patients showed statistically significant improvement in pain, joint function, and QoL. The robust GEE analysis revealed that the significant main effect of time was found fo.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
75% Alcohol Disinfectant	Shandong Lierkang Medical Technology Co., Ltd.	20190405A	Used for skin disinfection at the injection site to prevent infection
Disposable Syringe	Shandong Weigao Group Medical Polymer Products Co., Ltd.	20190821	Used to draw sodium hyaluronate injection for injection operations
Iodophor Disinfectant	Shanghai Likang Disinfection Technology Co., Ltd.	20190814J	Used for skin disinfection at the injection site to prevent infection
Lidocaine Hydrochloride Injection	Beijing Jiuneng Tianyuan Technology Co., Ltd.	1H 19031701	used for local anesthesia at the injection site with a specification of 2 mL vial)
Numerical Rating Scale (NRS) for Pain	N/A (a common tool)	N/A	Used to assess the patient's pain level and screen patients with an NRS score of ≥ 4 (on a scale of 0 - 10)
Sofast (Sodium Hyaluronate Injection)	Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd.	190302113	Used for ankle joint injection in enrolled patients, with a specification of 2 mL(20mg per vial)
The joint dysfunction index (JDI) for Kashin-beck disease (KBD)	N/A (a common tool)	N/A	Used for the measurement of therapeutic efficacy in KBD patients
The three-level EuroQol five-dimensional questionnaire (EQ-5D-3L)	the EuroQol Research Foundation	N/A	Used for assessing the quality of life of Kashin-Beck disease
X - ray Equipment	Toshiba Electron Tubes & Devices Co., Ltd.	E7876X	Used to take X - ray films of patients' hands and ankles to assist in determining whether they meet the inclusion criteria