• Users Online: 2061
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Contacts Login 
STUDY PROTOCOL
Year : 2018  |  Volume : 3  |  Issue : 1  |  Page : 15-21

Effectiveness and safety of arthroscopic debridement for treatment of degenerative knee osteoarthritis in elderly patients: study protocol for a non-randomized controlled trial


Second Hospital of Chaoyao, Chaoyang, Liaoning Province, China

Correspondence Address:
Yong-Chun Lu
Second Hospital of Chaoyao, Chaoyang, Liaoning Province
China
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3975.228987

Rights and Permissions

Background and objectives: The main treatment goals for degenerative knee osteoarthritis are 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 degenerative knee osteoarthritis; however, the cost is high, and the procedure is often associated with prosthesis loosening and shedding and many adverse reactions. Therefore, we hypothesize that knee-preserving arthroscopic debridement for treatment of knee degenerative osteoarthritis in elderly patients is lower-cost, effective, safe, and reliable. Design: Prospective, single-center, open-label, non-randomized controlled trial. Methods: In total, 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 each patient’s condition and wishes (n = 106/group). In the control group, intra-articular injection of sodium hyaluronate will be performed, followed by oral administration of nonsteroidal anti-inflammatory drugs, conventional physiotherapy, and quadriceps functional exercise. In the arthroscopic debridement group, arthroscopic debridement will be performed, followed by oral administration of nonsteroidal anti-inflammatory drugs, conventional physiotherapy, and quadriceps functional exercise. All patients will be followed up at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years. Outcome measures: The primary outcome measure is the percentage of patients with a Hospital for Special Surgery (HSS) knee score of ≥ 85 points at 2 years after surgery, which will be used to evaluate knee function recovery. The secondary outcome measures are the percentage of patients with an HSS knee score of ≥ 85 points before surgery and at 1 week, 1 month, 3 months, 6 months, and 1 year after surgery; the HSS score, visual analog scale score, Western Ontario and McMaster Universities Osteoarthritis Index, knee range of motion, hospitalization costs, and knee X-ray morphology before surgery and 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after surgery; medical costs after 2 years of treatment; and incidence of adverse reactions at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after surgery. Discussion: The findings from this study will reveal whether arthroscopic debridement for the treatment of degenerative knee osteoarthritis in elderly patients has the advantages of fewer adverse reactions and lower treatment costs with effective restoration of knee function. Ethics and dissemination: This study was approved by Medical Ethics Committee of Second Hospital of Chaoyang of China (approval No. 2017-08-01). The study will be performed in accordance with the Declaration of Helsinki. Participants provided signed informed consent regarding the study protocol prior to participation in the study. This study was designed in June 2017. Patient recruitment and data collection will begin in June 2018. Patient recruitment will end in December 2018. Data analysis will be performed in June 2021. The study will be completed in August 2021. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800015208). Protocol version (1.0).


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed5942    
    Printed465    
    Emailed0    
    PDF Downloaded367    
    Comments [Add]    
    Cited by others 1    

Recommend this journal