Effectiveness and safety of arthroscopic debridement for treatment of degenerative knee osteoarthritis in the elderly patients: study protocol for non-randomized controlled clinicaltrial
10.3969/j.issn.2095-4344.0121
- VernacularTitle:关节镜下病灶清理治疗老年膝关节退行性骨关节炎的有效性及安全性:非随机对照临床试验方案
- Author:
Yong-Chun LU
1
;
Bo BI
;
Yong-Sheng XIANG
;
Xiang-Yang DU
Author Information
1. 朝阳市第二医院
- From:
Chinese Journal of Tissue Engineering Research
2018;22(7):1084-1089
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND: The treatment of degenerative knee osteoarthritis is mainly to relieve pain, restore knee function, improve quality of life, delay knee replacement, and reduce the number of revisions. Knee replacement is currently the most common treatment for this disease, but it costs much, has great trauma and high risk, often results in prosthesis loosening and peripheral infection, and has many adverse reactions. OBJECTIVE: We hypothesize that knee-preserving arthroscopic debridement for treatment of knee degenerative osteoarthritis in the elderly patients costs less, is effective, safe, and reliable. METHODS: A total of 212 elderly patients (knees) with degenerative knee osteoarthritis who receive treatment in the Second Hospital of Chaoyang (Liaoning Province, China) will be included in this study. These patients will be assigned to two groups according to patient's conditions and wishes (n = 106/group). In the control group, intra-articular injection of sodium hyaluronate will be performed, followed by oral administration of non-steroidal anti-inflammatory drugs, conventional physiotherapy, and quadriceps functional exercise. In the arthroscopic debridement group, arthroscopic debridement will be performed followed by oral administration of non-steroidal anti-inflammatory drugs, conventional physiotherapy, and quadriceps functional exercise. All patients will be followed up for 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years. RESULTS AND CONCLUSION: The primary outcome measure is the percentage of the number of patients with Hospital for Special Surgery (HSS) knee score ≥ 85 points at 2 years after surgery, which will be used to evaluate knee function recovery. The secondary outcome measures are the percentage of the number of patients with HSS knee score ≥ 85 points before surgery, 1 week, 1 month, 3 months, 6 months, and 1 year after surgery; HSS score, Visual Analogue Scale (VAS) score, The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee range of motion, hospitalization costs, and knee X-ray morphology before surgery, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after surgery, medical costs after 2 years of treatment, incidence of adverse reactions at 1 week, 1 month, 3 months, 6 months, 1 year and 2 years after surgery. Findings from this study will reveal whether arthroscopic debridement for the treatment of degenerative knee osteoarthritis in the elderly patients has advantages of less adverse reactions, low treatment costs, and can effectively restore knee function. This trial has been approved by the Second Hospital of Chaoyang, Liaoning Province, China (approval number:2017-08-01).All protocols will be in accordance with Declaration of Helsinki,formulated by the World Medical Association.Written informed consent will be provided by participants. This trial was designed in June 2017. The recruitment of subjects and data collection will begin in June 2018. The recruitment of subjects will be finished in December 2018. Outcome measures will be analyzed in June 2021. This trial will be completed in August 2021. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800015208). The version of this study protocol is (1.0).
