Back to results6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
Primary Purpose
Osteoarthritis, Hip
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SYNOLIS VA 80/160
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Osteoarthritis, Hip osteoarthritis, Hyaluronic acid
Eligibility Criteria
Inclusion Criteria: Patient over 18 years of age, Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria: Treated hip pain: Oxford score ≥ 21/60, Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit), Symptoms related to osteoarthritis of the hip for at least 2 months, Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60), Informed consent form signed by the patient, The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old). Exclusion Criteria: Pregnancy, Participation in another clinical trial, Skin lesion near the injection site, Recent or old infection of the affected joint, Patient with a programmed arthroplasty, Patient with a pathology that makes decision-making impossible, The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.
Sites / Locations
- Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD
- Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SYNOLIS VA 80/160
Arm Description
Single guided intra-articular injection of SYNOLIS VA 80/160
Outcomes
Primary Outcome Measures
Evolution of the Oxford Hip Score (OXFORD 12)
Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.
Secondary Outcome Measures
Evolution of the Oxford Hip Score (OXFORD 12)
Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.
Self-assessment symptoms evolution
7-point Likert scale (-3 to +3)
MCID Oxford Hip Score (OXFORD 12)
Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)
Hip prosthesis placement after the injection
Number of Participants with Hip prosthesis placement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05829733
Brief Title
6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
Official Title
6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptissen SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Osteoarthritis, Hip osteoarthritis, Hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SYNOLIS VA 80/160
Arm Type
Experimental
Arm Description
Single guided intra-articular injection of SYNOLIS VA 80/160
Intervention Type
Device
Intervention Name(s)
SYNOLIS VA 80/160
Intervention Description
SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)
Primary Outcome Measure Information:
Title
Evolution of the Oxford Hip Score (OXFORD 12)
Description
Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.
Time Frame
6 months (M6)
Secondary Outcome Measure Information:
Title
Evolution of the Oxford Hip Score (OXFORD 12)
Description
Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.
Time Frame
Month 3, Month 3 to Month 6
Title
Self-assessment symptoms evolution
Description
7-point Likert scale (-3 to +3)
Time Frame
Month 3, Month 3 to Month 6
Title
MCID Oxford Hip Score (OXFORD 12)
Description
Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)
Time Frame
Month 3, Month 3 to Month 6
Title
Hip prosthesis placement after the injection
Description
Number of Participants with Hip prosthesis placement
Time Frame
Month 6
Other Pre-specified Outcome Measures:
Title
Safety and tolerability of SYNOLIS VA 80/160
Description
Serious adverse event occurrence
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient over 18 years of age,
Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria:
Treated hip pain: Oxford score ≥ 21/60,
Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit),
Symptoms related to osteoarthritis of the hip for at least 2 months,
Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60),
Informed consent form signed by the patient,
The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old).
Exclusion Criteria:
Pregnancy,
Participation in another clinical trial,
Skin lesion near the injection site,
Recent or old infection of the affected joint,
Patient with a programmed arthroplasty,
Patient with a pathology that makes decision-making impossible,
The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduard Vidovic, MD
Phone
+41225522104
Email
clinic@aptissen.com
Facility Information:
Facility Name
Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD
City
Dunkerque
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Jan, Dr
Facility Name
Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille
City
Lille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henri Migaud, Pr
12. IPD Sharing Statement
Learn more about this trial
6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
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