Outcome of lubricating drug injection into the knee joint after arthroscopic ligament reconstructio
Not Applicable
- Conditions
- Health Condition 1: M235- Chronic instability of knee
- Registration Number
- CTRI/2021/12/038715
- Lead Sponsor
- All India Institute of Medical Sciences Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients with symptomatic ACL tear willing to undergo ACLR
2.Age: 18-50 years
3.No associated osteochondral injury
4.Patients requiring partial meniscectomy will be included
5.There should not be axial malalignment in index length
6.Contralateral knee should be healthy
Exclusion Criteria
1.other ligament injury/ multi ligamentous injury
2.Severe meniscal injury requiring complete meniscectomy
3.Associated chondral defect requiring repair
4.Knee osteoarthritis
5.H/o associated knee joint fracture
6.Inflammatory, infective and metabolic conditions of the knee
7.Patients with chronic diseases of the heart, liver, kidney or major organ Associated dysfunction
8.H/o autoimmune illness, hematopoietic disease or bone tumor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the percentage of patients in each group (HA vs. placebo) who achieved clinically effective Lysholm score (83% Lysholm score) and able to join back their preinjury activity level (same or increased Tegner activity score) at the end of 3, 6 and 12 months.Timepoint: Baseline, 3 months, 6 months, 12 months
- Secondary Outcome Measures
Name Time Method a.To determine the median recovery time to achieve the Lysholm score of 83% in all groups / same or increased Tegner level compared to preinjury value <br/ ><br>b.To assess the level of activity of the patients in each group by dividing them into quick (able to run or jog, score 4 or 5) or delayed recovery (score 1-3, hard to walk, walking and stair climbing). <br/ ><br>c.To compare the pain (VAS score), function (single hop test, range of motion, knee circumference, IKDC score, Lysholm score, Tegner score) and quality of life (EQ-5D) between the groups. <br/ ><br>d.To look for synovial (IL1-beta, TNF-alfa and IL-6) and blood inflammatory markers (ESR, CRP) change with time in the groups <br/ ><br>e.To look for adverse reaction to the drug (HA). <br/ ><br>Timepoint: 6 months, 12 months