Osteo Arthritis KneeNO-DOLORNCT04196764
Prospective Observational Study of Pain Evolution in Patients With Primary Knee Osteoarthritis Treated With Pronolis® HD
An observational study of Osteo Arthritis Knee, run by Procare Health Iberia S.L. at 1 site in Spain.
Trial summary
Prospective observational study of 6 months of follow-up, of national and multicenter scope with medical device with CE marking and according to the usual clinical practice. In addition, due to the observational design of the clinical investigation, no assignment of the patients will be made to any specific study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- How many people
- 188 participants
- Where
- 1 siteSpain
- Study dates
- 28 May 2017to 21 Oct 2019
- 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: The study population will be made up of subjects of legal age diagnosed with primary knee osteoarthritis who have pain equal to or greater than 4 measured by VAS. All patients included in this clinical investigation must have been duly informed by the investigator about the investigation procedure and its objectives.
Who may be able to join
- Patients of both sexes and over 18 years.
- Patients with a previous diagnosis of primary knee osteoarthritis according to ACR criteria and who have a knee x-ray performed during the previous 18 months.
- Patients who attend a control clinic for primary osteoarthritis of symptomatic knee.
- Patients with pain equal to or greater than 4 on the VAS scale.
- Patients who have been prescribed an injection of Pronolis® HD as part of the usual clinical practice.
- Patients who have given their written informed consent to participate in the clinical investigation.
- Patients for whom there is a reasonable expectation of follow-up during the development of clinical research.
- Patients who understand and can complete the questionnaires and do not have cognitive impairment that prevents it.
Who cannot join
- Patients with known intolerance to hyaluronic acid.
- Patients with hypersensitivity to intraarticular injections.
- Patients who present with infection in the knee joint.
- Patients presenting with a skin disorder or infection in the area of injection or systemic.
- Coagulation disorders that contraindicate puncture.
- Patients who have been prescribed intra-articular injection in both knees.
Show all 11Show fewer
- Patients diagnosed with autoimmune rheumatologic diseases or connective diseases.
- Patients diagnosed with microcrystalline diseases.
- Patients with traumatic history in the study joint.
- Patients with a surgical history in the study joint.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estudio Observacional Del Seguimiento Prospectivo de la evolución Del Dolor en Pacientes Con Artrosis Primaria de Rodilla Tratados Con Pronolis® HD
Prospective observational study of 6 months of follow-up, of national and multicenter scope with medical device with CE marking and according to the usual clinical practice.
In addition, due to the observational design of the clinical investigation, no assignment of the patients will be made to any specific study group, but will be carried out in accordance with the usual clinical practice, not applying any intervention other than the usual one in this type of care practice and always in accordance with current clinical guidelines and recommendations and with the indications authorized in Spain.
Patients will be recruited by specialists and will be followed for 6 months under the conditions of usual clinical practice.
- Conditions
- Osteo Arthritis Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of pain in patients diagnosed with primary knee osteoarthritis 3 months after being treated with hyaluronic acid
3-month baseline change in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution.
Measured: 3 months
Secondary outcomes (8)
evolution of pain in patients diagnosed with primary knee osteoarthritis during the study
Changes in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution.
Measured: 15 days, 1 and 6 months
Pain evolution in motion
Average score of question A1 of the WOMAC questionnaire will be described at each study visit in order to evaluate pain evolution in motion of the affected joint.
Measured: 15 days, 1, 3 and 6 months
stiffness evolution
Average score of domain B of the WOMAC questionnaire will be described at each study visit in order to evaluate the evolution of the stiffness of the affected joint of the patient. In addition, the changes produced between the follow-up visits and the baseline visit will be studied.
Measured: 15 days, 1, 3 and 6 months
evolution of the patient's functional capacity
Average C domain score of the WOMAC questionnaire will be described at each study visit in orde to assess the evolution of the patient's functional capacity. In addition, the changes produced between the follow-up visits and the baseline visit will be studied.
Measured: 15 days, 1, 3 and 6 months
evolution of the patient's quality of life
Average score in the 5 dimensions of the Health Questionnaire EQ-5D-5L (mobility, personal care, usual activities, pain / discomfort, anxiety / depression) at the baseline visit and the 3 month visit in order to evaluate the evolution of the patient's quality of life. In addition, the changes produced between the 3-month visit and the baseline visit will be studied.
Measured: 3 months
satisfaction degree with Pronolis® HD
A likert type scale will be used to assess the patient's satisfaction degree with study treatment in each of the study visits. The evolution of the satisfaction degree (an 5-point Likert Scale) contains 5 items. Higher scores reflected better satisfaction degree
Measured: 15 days, 1, 3 and 6 months
overall clinical impression
For the evaluation of the overall clinical impression of the change by the patient, the ICG-C score will be described in all follow-up visits.
Measured: 15 days, 1, 3 and 6 months
tolerability of treatment with Pronolis® HD
percentage of patients who present adverse effects to the treatment during the observation period will be described in order to evaluate the tolerability of hyaluronic acid treatment
Measured: 15 days, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start28 May 2017
- Primary completion21 Feb 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196764
- Sponsor's protocol ID
- NO-DOLOR-2017-01
- Acronym
- NO-DOLOR
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Calvet J, Khorsandi D, Tio L, Monfort J. Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study. BMC Musculoskelet Disord. 2022 May 11;23(1):442. doi: 10.1186/s12891-022-05383-w.
PubMed 35546401
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Observacional Del Seguimiento Prospectivo de la evolución Del Dolor en Pacientes Con Artrosis Primaria de Rodilla Tratados Con Pronolis® HD
- ClinicalTrials.gov ID
- NCT04196764
- Acronym / sponsor ID
- NO-DOLOR / NO-DOLOR-2017-01
- Conditions
- Osteo Arthritis Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Study start
- 28 May 2017 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 12 Dec 2019 (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.
Prospective observational study of 6 months of follow-up, of national and multicenter scope with medical device with CE marking and according to the usual clinical practice.
In addition, due to the observational design of the clinical investigation, no assignment of the patients will be made to any specific study group, but will be carried out in accordance with the usual clinical practice, not applying any intervention other than the usual one in this type of care practice and always in accordance with current clinical guidelines and recommendations and with the indications authorized in Spain.
Patients will be recruited by specialists and will be followed for 6 months under the conditions of usual clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be made up of subjects of legal age diagnosed with primary knee osteoarthritis who have pain equal to or greater than 4 measured by VAS. All patients included in this clinical investigation must have been duly informed by the investigator about the investigation procedure and its objectives.
Key inclusion criteria (8 listed)
- Patients of both sexes and over 18 years.
- Patients with a previous diagnosis of primary knee osteoarthritis according to ACR criteria and who have a knee x-ray performed during the previous 18 months.
- Patients who attend a control clinic for primary osteoarthritis of symptomatic knee.
- Patients with pain equal to or greater than 4 on the VAS scale.
- Patients who have been prescribed an injection of Pronolis® HD as part of the usual clinical practice.
Key exclusion criteria (11 listed)
- Patients with known intolerance to hyaluronic acid.
- Patients with hypersensitivity to intraarticular injections.
- Patients who present with infection in the knee joint.
- Patients presenting with a skin disorder or infection in the area of injection or systemic.
- Coagulation disorders that contraindicate puncture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evolution of pain in patients diagnosed with primary knee osteoarthritis 3 months after being treated with hyaluronic acid
Time frame: 3 months
3-month baseline change in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution.
8 secondary outcomes
evolution of pain in patients diagnosed with primary knee osteoarthritis during the study
Time frame: 15 days, 1 and 6 months
Pain evolution in motion
Time frame: 15 days, 1, 3 and 6 months
stiffness evolution
Time frame: 15 days, 1, 3 and 6 months
evolution of the patient's functional capacity
Time frame: 15 days, 1, 3 and 6 months
evolution of the patient's quality of life
Time frame: 3 months
satisfaction degree with Pronolis® HD
Time frame: 15 days, 1, 3 and 6 months
overall clinical impression
Time frame: 15 days, 1, 3 and 6 months
tolerability of treatment with Pronolis® HD
Time frame: 15 days, 1, 3 and 6 months
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 21 Feb 2021.
- Derived from this study: PubMed 35546401Calvet J, Khorsandi D, Tio L, Monfort J. Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study. BMC Musculoskelet Disord. 2022 May 11;23(1):442. doi: 10.1186/s12891-022-05383-w.
- 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 Osteo Arthritis Knee, run by Procare Health Iberia S.L. at 1 site in Spain.
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 8 inclusion and 11 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 21 Feb 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 Spain. 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?
evolution of pain in patients diagnosed with primary knee osteoarthritis 3 months after being treated with hyaluronic acid (time frame: 3 months). 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 NCT04196764, which also lists 1 linked publication.
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 21 Feb 2021.