Prospective Observational Study of Pain Evolution in Patients With Primary Knee Osteoarthritis Treated With Pronolis® HD

NCT ID: NCT04196764

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-28
• Study Completion Date: 2019-10-21

Brief 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 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Patients of both sexes and over 18 years.

2. 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.

3. Patients who attend a control clinic for primary osteoarthritis of symptomatic knee.

4. Patients with pain equal to or greater than 4 on the VAS scale.

5. Patients who have been prescribed an injection of Pronolis® HD as part of the usual clinical practice.

6. Patients who have given their written informed consent to participate in the clinical investigation.

7. Patients for whom there is a reasonable expectation of follow-up during the development of clinical research.

8. Patients who understand and can complete the questionnaires and do not have cognitive impairment that prevents it.

Exclusion Criteria

1. Patients with known intolerance to hyaluronic acid.

2. Patients with hypersensitivity to intraarticular injections.

3. Patients who present with infection in the knee joint.

4. Patients presenting with a skin disorder or infection in the area of injection or systemic.

5. Coagulation disorders that contraindicate puncture.

6. Patients who have been prescribed intra-articular injection in both knees.

7. Patients diagnosed with autoimmune rheumatologic diseases or connective diseases.

8. Patients diagnosed with microcrystalline diseases.

9. Patients with traumatic history in the study joint.

10. Patients with a surgical history in the study joint.

11. Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adknoma Health Research

INDUSTRY

Sponsor Role: collaborator

Procare Health Iberia S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital del Mar

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35546401 (View on PubMed)

Other Identifiers

NO-DOLOR-2017-01

Identifier Type: -

Identifier Source: org_study_id