Evaluate Clinical Benefit of Local Treatment With KD Intra-Articular® Gel in Patients With Osteoarthritis (NO-DOLOR2)

NCT05275244 | Completed

• 1 other identifier: NO-DOLOR-2-2021-02
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational, national, multicentre, open study with a class III medical device with EC marking. Study to evaluate the clinical benefit of local treatment with KD intra-articular® gel in patients with osteoarthritis of the shoulder, hip, ankle or base of the thumb. The study will be conducted in the Rheumatology Service of Spanish Hospitals under the usual medical conditions, in accordance with routine clinical practice and following the internationally recognised precepts of good clinical practice of ICH and Declaration of Helsinki. The objective is to evaluate the evolution of pain in patients diagnosed with single or preferential symptomatic osteoarthritis of the shoulder or hip treated with KD Intra-Articular® gel 2.2% - 44 mg in 2 ml - (Pronolis® HD one 2.2%), and ankle or base of the thumb treated with KD Intra-Articular® gel 1.6% - 16 mg in 1 ml - (Pronolis® HD mini 1.6%). Eighty patients will be included among about 6 Spanish Sites. The study comprises a maximum of 6 visits per protocol. At visit 0, informed consent will be obtained, the patient will be checked for fulfil the selection criteria. A pain assessment will also be carried out using a Visual Analogue Scale (VAS) and the corresponding questionnaire will be completed depending on the affected joint. According to the usual clinical practice of the site, the study treatment will be administered. A week after the first infiltration the second visit (V1) will be applied, and the VAS will be repeated. The patient's global clinical impression of change will also be assessed, and along with the Likert scale of satisfaction will be collected. The next visit (V2) will be carried out a week after the second infiltration and the procedures will be the same as those of the previous visit (V1). At 4 (V3), 12 (V4) and 24 (V5) weeks after receiving the third infiltration (V2), follow-up visits will be carried out where the assessment procedures will be the same as in visit 0, in addition to the GCI -C, the Likert scale of satisfaction and the collection of potential AEs and changes in concomitant medication. At each visit, the patient will be given a diary, where they will collect the rescue medication they have needed since the previous visit. In the electronic case report form (eCRF), the rescue medication (analgesics and NSAIDs) that you have needed since the previous visit (V0-V2) or in the month prior to the study visit (V3-V6) will be collected.

Conditions

Osteoarthritis, Hip; Osteoarthritis Thumb; Osteoarthritis Ankle

Outcome Measures

Primary Outcomes (4)

• To evaluate the evolution of the change in ankle osteoarthritis pain.

  To evaluate the evolution of the change in ankle osteoarthritis pain, the Foot and Ankle Output Score (FAOS) questionnaire will be used. The mean questionnaire score at the 24-week visit versus baseline will be described.

  24 weeks

• To evaluate the evolution of the change in shoulder osteoarthritis pain.

  To evaluate the evolution of the change in shoulder osteoarthritis pain, the American Shoulder and Elbow Surgeons (ASES) questionnaire will be used. The mean questionnaire score at the 24-week visit versus baseline will be described.

  24 weeks

• To evaluate the evolution of the change in pain in base of thumb.

  To evaluate the evolution of the change in pain in base of thumb, the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used. The mean questionnaire score at the 24-week visit versus baseline will be described.

  24 weeks

• To evaluate the evolution of the change in hip osteoarthritis pain.

  To evaluate the evolution of the change in pain in base of thumb, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire will be used. The mean questionnaire score at the 24-week visit versus baseline will be described.

  24 weeks

Secondary Outcomes (6)

• Assessment of the Need for Rescue Analgesic Medication.

  24 weeks

• Assessment of the Clinical Evolution by the Patient (1/2).

  24 weeks

• Assessment of the Clinical Evolution by the Patient (2/2).

  24 weeks

• Assessment of the Change in Grip Strength in Patients with Osteoarthritis of the Base of the Thumb.

  24 weeks

• Evaluation of Patient Satisfaction with Treatment.

  24 weeks

Study Arms (1)

Osteoarthritis Group

The patients diagnosed with single or preferential symptomatic osteoarthritis of the shoulder or hip treated with KD Intra-Articular® gel 2.2% - 44 mg in 2 ml - (Pronolis® HD one 2.2%), and ankle or base of the thumb treated with KD Intra-Articular® gel 1.6% - 16 mg in 1 ml - (Pronolis® HD mini 1.6%). Each patient will be administrated three injections, one per week.

Device: KD Intra-Articular® gel

Interventions

KD Intra-Articular® gel DEVICE

Depending on the joint, 3 injections will be administrated to the patient: KD Intra-Articular® gel 2.2% - 44 mg in 2 ml - (Pronolis® HD one 2.2%) in the case of shoulder and hip, or KD Intra-Articular® gel 1.6% - 16 mg in 1 ml - (Pronolis® HD mini 1.6%) in the case of the ankle and base of the thumb. The administration of the infiltrations will be with an interval of one week.

Osteoarthritis Group

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 participation of 80 patients is expected (20 in each joint), diagnosed with osteoarthritis of the shoulder, hip, ankle or base of the thumb thanks to the collaboration of the rheumatology service of the public or private Spanish hospitals. The patients to be included in the study must meet all the above-mentioned screening criteria.

You may qualify if:

• Age equal to or greater than 18 years.
• Patients who come to a control consultation for single or preferential symptomatic osteoarthritis, primary in the case of the hip, shoulder or base of the thumb, or secondary post-traumatic in the case of the ankle.
• Patients who meet the ACR diagnostic criteria for osteoarthritis of the hip and base of the thumb. Patients who meet the AOFAS diagnostic criteria for ankle osteoarthritis and those for shoulder osteoarthritis defined in the literature.
• Patients with pain equal to or greater than 4 on the VAS pain scale.
• Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form.
• Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.

You may not qualify if:

• Known hypersensitivity to sodium hyaluronate or other study treatment components.
• Previous trauma or surgical intervention in the affected joint (except in ankle osteoarthritis).
• Swelling, exacerbation, or significant effusion in the affected joint.
• Septic and aseptic arthritis.
• Skin disorder or infection at the site of infiltration.
• Patients requiring intra-articular infiltration in two joints.
• Viscosupplementation of the affected joint within 6 months prior to the start of treatment.
• Infiltration of steroids in the affected joint in the 3 months prior to the start of treatment.
• History of autoimmune, microcrystalline rheumatological diseases or connective tissue diseases.
• Coagulation disorders and/or anticoagulant medication that contraindicates infiltration.
• Women who are pregnant, suspected of being pregnant or breastfeeding.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead

Study Sites (1)

Hospital Del Mar

Barcelona, 08003, Spain

Location

Related Publications (5)

• Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.

  PMID: 2025304 BACKGROUND

• Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10. doi: 10.1002/art.1780331101.

  PMID: 2242058 BACKGROUND

• Bryant D, Litchfield R, Sandow M, Gartsman GM, Guyatt G, Kirkley A. A comparison of pain, strength, range of motion, and functional outcomes after hemiarthroplasty and total shoulder arthroplasty in patients with osteoarthritis of the shoulder. A systematic review and meta-analysis. J Bone Joint Surg Am. 2005 Sep;87(9):1947-56. doi: 10.2106/JBJS.D.02854.

  PMID: 16140808 BACKGROUND

• Domsic RT, Saltzman CL. Ankle osteoarthritis scale. Foot Ankle Int. 1998 Jul;19(7):466-71. doi: 10.1177/107110079801900708.

  PMID: 9694125 BACKGROUND

• Lin W, Liu Z, Kampf N, Klein J. The Role of Hyaluronic Acid in Cartilage Boundary Lubrication. Cells. 2020 Jul 2;9(7):1606. doi: 10.3390/cells9071606.

  PMID: 32630823 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 11, 2022
• Study Start: March 17, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 14, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

ES (1)