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

NCT04196764 | Completed

• 1 other identifier: NO-DOLOR-2017-01
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (8)

• evolution of pain in patients diagnosed with primary knee osteoarthritis during the study

  15 days, 1 and 6 months

• Pain evolution in motion

  15 days, 1, 3 and 6 months

• stiffness evolution

  15 days, 1, 3 and 6 months

• evolution of the patient's functional capacity

  15 days, 1, 3 and 6 months

• evolution of the patient's quality of life

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead
• Adknoma Health Research: collaborator

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (1)

• 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.

  PMID: 35546401 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 12, 2019
• Study Start: May 28, 2017
• Primary Completion: February 21, 2019
• Study Completion: October 21, 2019
• Last Updated: February 21, 2021

Record last verified: 2019-12

Locations

ES (1)