Painful Unilateral Femorotibial Knee Osteoarthritis of Any EtiologyPhase 2GOTOXNCT02832713
Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis
A Phase 2 study testing Botulinum toxin A ( BoNT-A) and Hyaluronic acid (HA) in people with Painful Unilateral Femorotibial Knee Osteoarthritis of Any Etiology, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis. Currently, osteoarthritis management is based on three major axes: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Unilateral Femorotibial Knee Osteoarthritis of Any Etiology
- What is being tested?
- Botulinum toxin A ( BoNT-A) and Hyaluronic acid (HA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2017to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful, or predominantly unilateral painful, knee osteoarthritis of any etiology
- Knee without clinical signs of intra-articular effusion
- Kellgren score ≥ II on X-ray
- WOMAC pain sub-score ≥ 5 in the month preceding the inclusion visit
Who cannot join
- Clinical:
- Inflammatory arthropathy,infectious, neoplastic within the past year
- Neuromuscular pathology
- Cardiorespiratory pathology or any other severe disease that interferes with the functional capacities
- Any decompensated or unstable chronic pathology
- Glomerular filtration rate (GFR)<15 mL/min/1.73m²) within the past 6 months
Show all 22Show fewer
- HBA1c in diabetic people > 12% within the past 6 months
- BMI ≥ 35kg/m2
- Infection: joint, general, distant, cutaneous
- Foreign material in the knee to be treated: prosthesis, osteosynthesis material
- Severe coagulation problem: platelets <100000/mm3 within the past 6 months
- Allergy to BoNT-A
- Allergy to HA
- Pregnant or breast-feeding women
- Treatment with aminoglycosides or direct oral anticoagulants
- Treatment with VKA (antihemorrhagic vitamin) if INR (International Normalized Ratio) higher than 3 within the past month
- Change of anti-pain treatment less than 2 weeks before enrolment
- Treatment with III pain killers or corticosteroids because of intense pain that does not respond to schedule I and II pain-killers
- Intra-articular injection of corticosteroids in the previous two months
- Viscosupplementation and/or injection of BoNT-A in the knee to be treated within the past 6 months
- Injection of BoNT-A (except the knee to be treated) within the past 3 months
- Swallowing troubles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis
In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis.
Currently, osteoarthritis management is based on three major axes:
- Non-pharmacological means, such as patient education, loss of weight and physical activity
- General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent.
- Intra-articular pharmacological treatments:
- Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups
- Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis.
- Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment.
- The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.
- Being tested
- Botulinum toxin A ( BoNT-A), Hyaluronic acid (HA)
- Keywords
- Knee osteoarthritis, Intra-articular botulinum toxin, Hyaluronic acid, Pain, Function
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A ( BoNT-A)Drug
Intra-articular injection of BoNT-A
Hyaluronic acid (HA)Device
Intra-articular injection of Hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular injection of botulinum toxin A | Experimental | Not described Receives: Drug: Botulinum toxin A ( BoNT-A) |
| Intra-articular injection of hyaluronic acid | Active comparator | Not described Receives: Device: Hyaluronic acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain measured using the WOMAC pain sub-score
Measured: Change from baseline WOMAC pain sub-score at 3 months
Secondary outcomes (8)
Evaluation of the antalgic effect of BoNT-A vs hyaluronic acid measured using a verbal rating scale (VRS)
Measured: 1 week after injection
Evaluation of the patients' functional improvement based on the WOMAC score ("stiffness and function sub-score" and total score)
Measured: Before injection, 1 month, 3 months and 6 months following injection
Evaluation of the patients' functional improvement using the Timed Up-and-go Test
Measured: Before injection, 1 month, 3 months and 6 months following injection
Evaluation of the quality of life based on the SF-36 score
Measured: Before injection, 1 month, 3 months and 6 months following injection
Frequency, seriousness and severity of adverse event reactions
Measured: during the 6 months following injection
Changes in pain treatment score (using a correspondence table)
Measured: Change from baseline pain treatment score at 6 months
Changes in muscular strenght et muscular trophicity (using dynanometer and measure of knee and thin circumference)
Measured: Before injection, 1 month, 3 months and 6 months following injection
Changes in passive and active articular knee amplitude, by goniometry
Measured: Before injection, 1 month, 3 months and 6 months following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start9 Jun 2017
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Unilateral Femorotibial Knee Osteoarthritis of Any EtiologyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832713
- Sponsor's protocol ID
- 6122
- Acronym
- GOTOX
- Status last verified
- Sep 2021
- First submitted
- 27 May 2016
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02832713
- Acronym / sponsor ID
- GOTOX / 6122
- Keywords
- Knee osteoarthritis, Intra-articular botulinum toxin, Hyaluronic acid, Pain, Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis.
Currently, osteoarthritis management is based on three major axes:
- Non-pharmacological means, such as patient education, loss of weight and physical activity
- General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent.
- Intra-articular pharmacological treatments:
- Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups
- Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis.
- Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment.
- The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular injection of botulinum toxin A | Experimental | Drug: Botulinum toxin A ( BoNT-A) |
| Intra-articular injection of hyaluronic acid | Active comparator | Device: Hyaluronic acid (HA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Painful, or predominantly unilateral painful, knee osteoarthritis of any etiology
- Knee without clinical signs of intra-articular effusion
- Kellgren score ≥ II on X-ray
- WOMAC pain sub-score ≥ 5 in the month preceding the inclusion visit
Key exclusion criteria (22 listed)
- Inflammatory arthropathy,infectious, neoplastic within the past year
- Neuromuscular pathology
- Cardiorespiratory pathology or any other severe disease that interferes with the functional capacities
- Any decompensated or unstable chronic pathology
- Glomerular filtration rate (GFR)<15 mL/min/1.73m²) within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin A ( BoNT-A)Intra-articular injection of BoNT-A | Drug | Intra-articular injection of botulinum toxin A |
| Hyaluronic acid (HA)Intra-articular injection of Hyaluronic acid | Device | Intra-articular injection of hyaluronic acid |
Primary outcome
Evaluation of pain measured using the WOMAC pain sub-score
Time frame: Change from baseline WOMAC pain sub-score at 3 months
8 secondary outcomes
Evaluation of the antalgic effect of BoNT-A vs hyaluronic acid measured using a verbal rating scale (VRS)
Time frame: 1 week after injection
Evaluation of the patients' functional improvement based on the WOMAC score ("stiffness and function sub-score" and total score)
Time frame: Before injection, 1 month, 3 months and 6 months following injection
Evaluation of the patients' functional improvement using the Timed Up-and-go Test
Time frame: Before injection, 1 month, 3 months and 6 months following injection
Evaluation of the quality of life based on the SF-36 score
Time frame: Before injection, 1 month, 3 months and 6 months following injection
Frequency, seriousness and severity of adverse event reactions
Time frame: during the 6 months following injection
Changes in pain treatment score (using a correspondence table)
Time frame: Change from baseline pain treatment score at 6 months
Changes in muscular strenght et muscular trophicity (using dynanometer and measure of knee and thin circumference)
Time frame: Before injection, 1 month, 3 months and 6 months following injection
Changes in passive and active articular knee amplitude, by goniometry
Time frame: Before injection, 1 month, 3 months and 6 months following injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin A ( BoNT-A) and Hyaluronic acid (HA) in people with Painful Unilateral Femorotibial Knee Osteoarthritis of Any Etiology, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain measured using the WOMAC pain sub-score (time frame: Change from baseline WOMAC pain sub-score at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.