Comparison of the effect of multiple needle puncturing and subperiosteal elevation of MCL on clinical and radiographic outcomes of patients undergoing total knee arthroplasty in patients with osteoarthritis with severe varus deformity, a double-blind randomization clinical trial
The aim of our study is to evaluate the clinical and radiographic results of the knee by multiple needle puncture method compared to the subperiosteal elevation method of MCL in patients undergoing total knee arthroplasty with severe varus osteoarthritis knee.
Design
Double-Blind randomized clinical trial With a parallel design of a phase 3 study ( The method of random blocks and considering 29 blocks of 6 for 174 patients into two groups of intervention and control Will be produced by the online site https://www.sealedenvelope.com)
Settings and conduct
In this double blind randomized clinical trial, Severe varus osteoarthritis knee patients undergoing primary total knee arthroplasty will be enrolled. Patients referred to our orthopedic academic center (Poursina hospital) after obtaining informed consent will be divided randomly to two groups of intervention (multiple needle puncturing) and control (subperiosteal elevation).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Severe varus osteoarthritis knee patients undergoing primary total knee arthroplasty, varus angle of above 15 degrees, the age group of 55 years to above, individual consent for participation in the study
Exclusion criteria: Any history of knee surgery, valgus knees, bone grafting for a severe deformity or bone defect, rheumatoid arthritis, neuromuscular problems including severe spinal disease
Intervention groups
Intervention group: Multiple needle puncturing for release MCL
Control group: Subperiosteal elevation for release MCL
Main outcome variables
Femorotibial angle, Knee society score (KSS), womac score, Complications of surgery (infection, hematoma, DVT)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110809007274N18
Registration date:2022-05-09, 1401/02/19
Registration timing:registered_while_recruiting
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of multiple needle puncturing and subperiosteal elevation of MCL on clinical and radiographic outcomes of patients undergoing total knee arthroplasty in patients with osteoarthritis with severe varus deformity, a double-blind randomization clinical trial
Public title
Effect two methods of multiple needle puncturing and subperiosteal elevation of MCL undergoing total knee arthroplasty in patients with osteoarthritis with severe varus deformity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe varus osteoarthritis knee patients undergoing primary total knee arthroplasty
Varus angle of above 15 degrees
The age group of 55 years to above
Individual consent for participation in the study
Exclusion criteria:
Any history of knee surgery
Valgus knees
Bone grafting for a severe deformity or bone defect
Rheumatoid arthritis
Neuromuscular problems, including severe spinal disease
Age
From 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
174
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, according to the estimated sample size, the online site https://www.sealedenvelope.com will be used to generate a randomization list of individuals to study groups. Based on the method of random blocks and considering 29 blocks of 6 for 174 patients into two groups of intervention and control Will be produced by the site. Eligible patients will be Randomly allocationed to two groups: multiple needle puncturing(87 patients) and subperiosteal elevation (87 patients).
To ensure blinding, consecutively-numbered sealed envelopes will be used during the randomization process, and the envelope pertaining to each person will be opened only after confirming the candidate’s eligibility and their signing of the consent form.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind study and the patients under study do not know the type of surgical intervention process. The evaluator will also be an orthopedic assistant who is not present in the treatment process of these patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan university of medical sciences
Street address
Guilan University of Medical Sciences' Headquarters, In front of 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St.,Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
41937-13194
Approval date
2022-04-06, 1401/01/17
Ethics committee reference number
IR.GUMS.REC.1401.008
Health conditions studied
1
Description of health condition studied
Osteoarthritis with severe varus deformity
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee society score (KSS)
Timepoint
Before and 3 and 6 months after surgery
Method of measurement
Based on KSS questionnaire
2
Description
womac score
Timepoint
Before and 3 and 6 months after surgery
Method of measurement
Based on womac questionnaire
3
Description
Femorotibial angle
Timepoint
Before and 3 and 6 months after surgery
Method of measurement
Based on varus angle(Radiography)
4
Description
Infection
Timepoint
After surgery
Method of measurement
Wound discharge during examination
5
Description
hematoma
Timepoint
After surgery
Method of measurement
hematoma after surgery
6
Description
Deep vein thrombosis (DVT)
Timepoint
After surgery
Method of measurement
Incidence of DVT after surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Multiple needle puncturing for release MCL underwent total knee arthroplasty in patients with osteoarthritis with severe varus deformity
Category
Treatment - Surgery
2
Description
Control group: Subperiosteal elevation for release MCL underwent total knee arthroplasty in patients with osteoarthritis with severe varus deformity