Critical Analysis of Hyaluronic Acid Study for Hip Osteoarthritis

This assignment presents a critical analysis of a research article investigating the efficacy of intra-articular injections of high molecular weight hyaluronic acid for treating hip osteoarthritis. The analysis, conducted using a critical appraisal worksheet, evaluates the study's research design, question, validity, and results, including the Brief Pain Inventory (BPI) and Harris Hip Score. The study, which did not compare hyaluronic acid with corticosteroid injections, was found to have limitations in randomization and blinding. However, the study showed statistically and clinically significant improvements in pain and hip function following treatment with hyaluronic acid, with stable results observed after 3 months and continued improvement up to a year. The assignment concludes that the article should be included in a capstone project due to the positive outcomes observed.

Critical Article Analysis Validity Form for RCTs/Therapy studies
Group Members: Gulzeb Memon and Bing Wang
PICO Question: Does intra-articular injection of Hyaluronic acid provide more clinical efficacy than
standard corticosteroid injection in managing patients with major joint osteoarthritis?
Article Citation and Link: Single intra-articular injection of high molecular weight hyaluronic acid for
hip osteoarthritis.
https://www.ncbi.nlm.nih.gov/pubmed/26449357
Critical Appraisal Worksheet YES PARTIAL/
UNKNOWN
NO SCORE
SCREENING
Did the study’s research design meet your inclusion criteria?
If partial or no, explain: Inpatients and outpatients were not defined. Comparison with
Intra-articular corticosteroid injection was not carried out. There are a number of
relevant peer reviewed articles which were not included.
3 2 1 2
What was the study’s research question?
The objective of the research article was to determine the safety and efficacy of intra-
articular injection of a high molecular weight hyaluronic acid (Coxarthrum) for the
treatment of hip osteoarthritis.
Does the study’s research question (PICO) match your question PICO?
The question does not compare the efficacy of intra-articular injections of
corticosteroid and hyaluronic acid.
3 2 1 2
VALIDITY
Was the assignment of patients to treatments randomized?
Centralized computer randomization is ideal; the METHODS section should tell you
how patients were allocated to groups and if randomization was concealed.
Explain your answer: The patients were allocated to groups based on the presence
of partial hip disease, affected by hip disease for 3 months and those with good joint
mobility. However, they carried out an unblinded study which is not favorable for
randomized clinical trials.
3 2 1 1
Were the groups similar at the start of the trial?
Look in the RESULTS section for description of group similarity; a table may
compare groups on a number of variables that may affect the outcome – ie age, risk
factors, etc.
Explain if partial or no: A table is not provided that compares the variable outcomes
associated with age of the patients and risk factors.
3 2 1 1
Aside from the allocated treatment, were the groups treated equally? Yes
There should be no additional treatments or tests; look in METHODS section.
Explain if partial or no: 3 2 1 3
Blinding: Were patients, health workers, and/or study personnel “blind” to
treatment?
It was an unblinded study.
Double blinding is best – both patients and investigators are unaware of treatment
allocation; look in METHODS.
3 2 1 1
Subject Mortality: Were all patients who entered the trial properly accounted
for and attributed at its conclusion?
Yes, it was between 0.5%.
Losses to follow-up should be less than 20%; the RESULTS section will clarify the
number and reason for losses to follow-up. Patients should be analyzed in the
groups to which they were randomized (“intention to treat analysis”).
3 2 1 3
1

STUDY RESULTS
What were the main results of the study? List main results.
Highly significant changes in the Brief Pain Inventory (BPI) score between baseline
(T0) and after 3, 6 and 12 months following treatment.
BPI changes were highly significant in case of the worst pain category after 6 months
of treatment.
BPI changes were highly significant in case of the mean pain category after 6 months
of treatment.
The Harris Hip Score was also significant before and after treatment. The score was
stable after 3 months of treatment.
No adverse cases were noted.
12 cases were associated with pain as a result of transient synovitis.
How large was the treatment effect?
a. Relative Risk (RR) of <1 means the treatment decreases the risk of the
outcome; >1 means the treatment increased the risk of the outcome; and =1
means no effect.
b. Relative Risk Reduction (RRR) tell us the reduction in the rate of the
outcome in the treatment group relative to that in the control group.
Assign a score based on the effectiveness of the treatment (3,2,1).
Explain your answer:
A sterile, transparent, homogenous and viscoelastic preparation consisting of a pure
form of hyaluronic acid was used. It did not contain any avian protein and was not
crosslinked to a chemical agent, which reduces the risk of allergy and other cytotoxic
reactions. Injections were given following fluoroscopic guidance.
3 2 1 3
Was the power (effect size) of the study adequate?
This may be in the METHODS or DISCUSSION; if so, indicate power value.
Explain your answer:
Patients were divided into those who have partial hip disease, prevailing hip disease
for at least 3 months and those with good mobility of joints. 207 patients were taken
and BPI, Harris Hip Score were determined. A single high molecular weight
hyaluronic acid dosage was found to be safe. It was found to be effective to control
pain in patients suffering from hip arthritis.
3 2 1
3
Are the results clinically as well as statistically significant?
Explain: Statistically significant scores were obtained in case of BPI and Harris Hip
Score following treatment. The results were also clinically significant as a single
hyaluronic acid dosage was found to be effective for treatment in the aspect of the
worst case scenario. 3 2 1
3
TOTAL SCORE(30 maximum) XXX XXX XX 22
This article is to be
___Yes____INCLUDED or
_______EXCLUDED for future analysis in our Capstone Project.
Explain your rationale:
This article should be included for future analysis in Capstone project, since it describes the effect of a single
dosage of hyaluronic acid for treatment of hip osteoarthritis. The results appear to be stable after 3 months of
administration and continuous improvement is observed for up to 1 year.
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