Osteoarthritis of Knee Clinical Trial
Official title:
Clinical Efficacy and Safety of NEOIAL HC (Hyaluronic Acid + Collagen) for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
Verified date | June 2023 |
Source | Nextrasearch S.r.l.s. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to the World Health Organization. The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA) leads to a slow, prolonged pain relief (up to six months after the first injection); On the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis. The present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA
Status | Completed |
Enrollment | 15 |
Est. completion date | August 9, 2022 |
Est. primary completion date | August 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age - Knee OA - VAS > 3 - Kellegren radiographic stage 3-4 Exclusion Criteria: - presence of joint effusion, - VAS score <3 according to the American College of Rheumatology Criteria - neoplasms, - haematological diseases, - specific rheumatological pathologies, - bleeding disorders, local infections, - refusal or non-compliance of the patient, - candidacy for knee joint replacement or any intra-articular injection during the previous year, - addiction to opioid drugs, - recent heart attack or stroke. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale SS Annunziata | Chieti |
Lead Sponsor | Collaborator |
---|---|
Nextrasearch S.r.l.s. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | occurrence of AEs and serious adverse events (SAEs) | reported on patients' open questionnaires, related or not to the product or procedures, abnormal laboratory results in terms of hematology, serum chemistry, and coagulation parameters, and clinically relevant findings at physical examination (including vital signs) during the entire study duration | through study completion, an average of 1 year | |
Primary | VAS score | The primary objective in the study was to evaluate the mean changes from baseline at Month 3 in VAS Pain Subscale Score | 6 months | |
Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS is self-administered and assesses 5 domains: pain, symptoms, activities of daily living (ADL), sport and recreation function, and knee-related quality of life. This scale is used to evaluate knee function in terms of activities of daily living (ADL). | 6 months | |
Secondary | Lequesne | measure the severity for osteoarthritis for the knee (ISK). This can be used to assess the effectiveness of therapeutic interventions | 6 months | |
Secondary | Western Ontario McMaster Universities (WOMAC®) VA3.1 | self-administered, patient-centered health status questionnaires allowing a thorough evaluation of pain, stiffness, and knee function (24 questions through three subscales) | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03274713 -
Efficacy of Electro-acupuncture Versus Manual Acupuncture on Knee Osteoarthritis
|
N/A | |
Completed |
NCT04535596 -
Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis
|
N/A | |
Completed |
NCT03918291 -
Whole-body Vibration Training on Functional Performance of the Elderly With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06263517 -
Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients
|
Phase 2/Phase 3 | |
Completed |
NCT01453738 -
Allogeneic Mesenchymal Stem Cells in Osteoarthritis
|
Phase 2 | |
Active, not recruiting |
NCT01027819 -
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT01186211 -
Feasibility of Outpatient Total Knee Arthroplasty
|
||
Active, not recruiting |
NCT00261066 -
Outcome Following Orthopaedic Surgery
|
||
Completed |
NCT03484910 -
Biofeedback With Cycling Exercise in OA Knee Patients
|
N/A | |
Recruiting |
NCT03884374 -
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
|
N/A | |
Completed |
NCT03492320 -
Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
|
||
Completed |
NCT01449552 -
Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT
|
N/A | |
Completed |
NCT06254976 -
Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 Levels in Knee Osteoarthritis
|
N/A | |
Completed |
NCT03428893 -
Mobile Technology to Support Physical Therapy Exercise
|
N/A | |
Completed |
NCT05081921 -
Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases
|
Phase 1/Phase 2 | |
Completed |
NCT02850068 -
Geniculate Artery Embolization for the Treatment of Knee Pain
|
N/A | |
Active, not recruiting |
NCT03110172 -
Short-term Efficacy of Antidepressant in Patients Underwent TKA
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT02623660 -
Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery
|
N/A | |
Completed |
NCT02579174 -
Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation
|
N/A | |
Completed |
NCT00790985 -
Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee
|
N/A |