Knee OsteoarthritisPRESAGENCT04988698
Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis
An observational study of Knee Osteoarthritis, run by Hopital Nord Franche-Comte at 1 site in France.
Trial summary
Knee osteoarthritis is a frequent condition whose prevalence is estimated at 7.6% of the French population aged 40 to 75, or approximately 2 million individuals . Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis recommended by a large number of learned societies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- none intervention
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2021to 27 Feb 2023
- Phase
- Observational
- 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
Study population: A questionnaire is administered by the investigator during the medical consultation. No act is performed outside of patient care.
Who may be able to join
- All adult outpatients, of both sexes, regardless of age, with a doctor-accepted diagnosis of knee OA and who have been treated with SV within the past 3 years
Who cannot join
- Patients who have not been treated with SV in the past 3 years.
- Patients who have been treated with VS for an indication other than osteoarthritis of the knee.
- Patients in whom the assessment could not be performed reliably
Trial locations and contacts
1 site in 1 country.
About this study
Knee osteoarthritis is a frequent condition whose prevalence is estimated at 7.6% of the French population aged 40 to 75, or approximately 2 million individuals . Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis recommended by a large number of learned societies. It consists of the intra-articular injection (IA) of hyaluronic acid (HA), to reduce knee pain by restoring normal joint homeostasis impaired by endogenous HA deficiency.
The IA administration of HA can be performed using 2 protocols: repeated weekly injections (3, sometimes 5 injections) and single injections. To date and there is no argument to favor either protocol. Regardless of the formula used, the safety of HA is excellent (RR of adverse reaction versus saline = 1.01, 95% CI 0.96-1.07, P = 0.6). The indication for viscosupplementation is the symptomatic treatment of mild to moderate knee osteoarthritis after failure and / or intolerance of analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs). In this indication, after HA injection the responder rate is in the order of 70% to 75% at 6 months and approximately 50% at 12 months. However, the predictors of the duration of effectiveness of SV are still unknown. The objective of the study is to research the factors influencing the duration of the effectiveness of SV, under real life conditions.
- Conditions
- Knee Osteoarthritis
- Being tested
- none intervention
- Keywords
- viscosupplementation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
none intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the factors influencing the duration of the effectiveness of SV, under real-life conditions
Duration (in weeks) during which the patient was satisfied with the treatment
Measured: At inclusion
Secondary outcomes (1)
Research for predictive factors will be carried out on the duration of satisfaction
Research for predictive factors will be carried out on the duration of satisfaction
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start4 May 2021
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988698
- Sponsor's protocol ID
- 2021-A00773-38
- Acronym
- PRESAGE
- Status last verified
- Jun 2023
- First submitted
- 15 Jul 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dollinger A, Lohse T, Dolci C, Rapp C, Bourgoin C, Lohse A, Conrozier T. Can Certain Antihypertensives Prolong the Efficacy of Hyaluronic Acid Injections in Patients with Osteoarthritis of the Knee? Post Hoc Analysis of a Prospective Observational Trial (PRESAGE). J Clin Med. 2026 Mar 4;15(5):1935. doi: 10.3390/jcm15051935.
PubMed 41827352Perruchet S, Balblanc JC, Rapp C, Bourgoin C, Guillochon C, Lohse A, Conrozier T. The Association between Radiographic Features and the Duration of Effectiveness of a Single Injection of Extended-Release Hyaluronic Acid (HANOX-M-XL) in Patients with Knee Osteoarthritis: Preliminary Results of a Prospective Trial. Cartilage. 2023 Jun;14(2):136-143. doi: 10.1177/19476035221109230. Epub 2022 Dec 17.
PubMed 36527367
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis
- ClinicalTrials.gov ID
- NCT04988698
- Acronym / sponsor ID
- PRESAGE / 2021-A00773-38
- Conditions
- Knee Osteoarthritis
- Keywords
- viscosupplementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 3 Aug 2021 (actual)
- 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.
Knee osteoarthritis is a frequent condition whose prevalence is estimated at 7.6% of the French population aged 40 to 75, or approximately 2 million individuals . Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis recommended by a large number of learned societies. It consists of the intra-articular injection (IA) of hyaluronic acid (HA), to reduce knee pain by restoring normal joint homeostasis impaired by endogenous HA deficiency.
The IA administration of HA can be performed using 2 protocols: repeated weekly injections (3, sometimes 5 injections) and single injections. To date and there is no argument to favor either protocol. Regardless of the formula used, the safety of HA is excellent (RR of adverse reaction versus saline = 1.01, 95% CI 0.96-1.07, P = 0.6). The indication for viscosupplementation is the symptomatic treatment of mild to moderate knee osteoarthritis after failure and / or intolerance of analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs). In this indication, after HA injection the responder rate is in the order of 70% to 75% at 6 months and approximately 50% at 12 months. However, the predictors of the duration of effectiveness of SV are still unknown. The objective of the study is to research the factors influencing the duration of the effectiveness of SV, under real life conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A questionnaire is administered by the investigator during the medical consultation. No act is performed outside of patient care.
Key inclusion criteria (1 listed)
- All adult outpatients, of both sexes, regardless of age, with a doctor-accepted diagnosis of knee OA and who have been treated with SV within the past 3 years
Key exclusion criteria (3 listed)
- Patients who have not been treated with SV in the past 3 years.
- Patients who have been treated with VS for an indication other than osteoarthritis of the knee.
- Patients in whom the assessment could not be performed reliably
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 |
|---|---|---|
| none interventionnone intervention | Other | – |
Primary outcome
Investigate the factors influencing the duration of the effectiveness of SV, under real-life conditions
Time frame: At inclusion
Duration (in weeks) during which the patient was satisfied with the treatment
1 secondary outcome
Research for predictive factors will be carried out on the duration of satisfaction
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 41827352Dollinger A, Lohse T, Dolci C, Rapp C, Bourgoin C, Lohse A, Conrozier T. Can Certain Antihypertensives Prolong the Efficacy of Hyaluronic Acid Injections in Patients with Osteoarthritis of the Knee? Post Hoc Analysis of a Prospective Observational Trial (PRESAGE). J Clin Med. 2026 Mar 4;15(5):1935. doi: 10.3390/jcm15051935.
- Derived from this study: PubMed 36527367Perruchet S, Balblanc JC, Rapp C, Bourgoin C, Guillochon C, Lohse A, Conrozier T. The Association between Radiographic Features and the Duration of Effectiveness of a Single Injection of Extended-Release Hyaluronic Acid (HANOX-M-XL) in Patients with Knee Osteoarthritis: Preliminary Results of a Prospective Trial. Cartilage. 2023 Jun;14(2):136-143. doi: 10.1177/19476035221109230. Epub 2022 Dec 17.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Knee Osteoarthritis, run by Hopital Nord Franche-Comte 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jun 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigate the factors influencing the duration of the effectiveness of SV, under real-life conditions (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988698, which also lists 2 linked publications.
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 22 Jun 2023.