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Osteoarthritis Ankle clinical trials

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NCT ID: NCT05912153 Recruiting - Osteoarthritis Clinical Trials

SPECT-CT vs MRI for the Diagnosis of Osteoarthritis in the Foot and Ankle

Start date: July 4, 2023
Phase:
Study type: Observational [Patient Registry]

The diagnose of symptomatic osteoarthritis in the ankle, mid- and hind foot remains challenging. There is no gold standard for the work-up and various hospitals use different protocols. Current literature shows a promising role for SPECT-CT imaging in ankle, hind- and midfoot OA. In a previous study investigating the role of SPECT-CT in a reproducible group we have observed a change in diagnosis in 53% when SPECT-CT data was added to the data of conventional workup alone. In 26% of patients addition of SPECT-CT data resulted in change of the original treatment plan. To our knowledge no prospective studies are available on this subject for both SPECT-CT and MRI. In our clinic both SPECT-CT and MRI are used in the work-up for patients with ankle, hind- and midfoot pain. Although we experience good result with SPECT-CT, MRI might be able to detect symptomatic OA as well. Moreover MRI provide more information about soft tissue and is less harmful for the patient in comparison to SPECT-CT. The aim of this study is to determine the diagnostic performance of SPECT-CT and MRI when used routinely in patients with symptomatic OA of the ankle, hind- and midfoot.

NCT ID: NCT05275244 Completed - Osteoarthritis, Hip Clinical Trials

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

NO-DOLOR2
Start date: March 17, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05209347 Withdrawn - Ankle Fractures Clinical Trials

Custom Dynamic Orthoses to Reduce Articular Contact Stress

PRMRP FPA CT
Start date: December 2024
Phase: N/A
Study type: Interventional

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle. Research suggests that ankle arthritis develops following ankle fracture due, in part, to elevated forces on the cartilage. It is expected that carbon fiber braces can reduce forces in the ankle joint thereby reducing the risk of developing arthritis following injury. In this study, carbon fiber braces will be tested to determine how they influence the forces acting on the ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design carbon fiber braces to effectively reduce forces on ankle cartilage.

NCT ID: NCT04770870 Recruiting - Clinical trials for Osteoarthritis Ankle

Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.

NCT ID: NCT04640974 Completed - Clinical trials for Osteoarthritis, Ankle

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint

Start date: January 14, 2021
Phase: N/A
Study type: Interventional

This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal® used for the symptomatic relief of osteoarthritis in the ankle joint.

NCT ID: NCT04562896 Completed - Ankle Fractures Clinical Trials

Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress

PRMRP-FPA2
Start date: January 8, 2020
Phase: N/A
Study type: Interventional

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.

NCT ID: NCT04204278 Completed - Clinical trials for Osteoarthritis Ankle

MONOVISC for Ankle Joint Pain Relief

Start date: December 11, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for ankle osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving ankle joint pain to 6 months post-treatment.

NCT ID: NCT03711773 Recruiting - Osteoarthritis Clinical Trials

Outcomes of Low-Impact Exercise Program for People With Ankle, Knee, and/or Hip Pain

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to study how low-impact group exercise classes affect pain scores in patients with knee, hip, and ankle pain when paired with concurrent standard of care dietitian and behavioral health consults.