Losartan to Improve Hip Microfracture

Status Terminated

Clinical Trial Summary

Phase I/IIA randomized, double-blind, placebo-controlled clinical trial to assess safety and efficacy of oral losartan for improving cartilage repair following microfracture to treat focal cartilage defects during hip arthroscopy.

Clinical Trial Description

This is a prospective, double-blind, placebo-controlled, randomized clinical trial that will be conducted at The Steadman Clinic and Steadman Philippon Research Institute. Articular cartilage defects that extend full thickness to subchondral bone rarely heal without intervention. Some patients may not develop clinically significant problems from acute full-thickness chondral defects, but many eventually suffer from debilitating degenerative changes. Microfracture is the most commonly used first-line treatment technique for chondral lesions in the hip, however, this procedure's effectiveness is limited by the repair tissue being a hybrid of hyaline and fibrocartilage. We hypothesize that administration of a transforming growth factor beta 1 (TGF-β1) blocker, losartan (an approved hypertension drug, angiotensin II receptor antagonist) with microfracture will enhance articular cartilage repair as assessed on quantitative magnetic resonance imaging. We will also measure patient benefit through the recording of patient reported outcomes in the 18 months following surgery. The Division of Pulmonary, Allergy and Rheumatology Products within the Center for Drug Evaluation and Research at the Food and Drug Administration has granted an investigational new drug (IND) exemption to pursue this trial in accordance with 21 CFR 312.2(b). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04212650
Study type	Interventional
Source	Steadman Philippon Research Institute
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	August 7, 2020
Completion date	December 4, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03326804` - H1 Hip Resurfacing Arthroplasty
Not yet recruiting	`NCT04257682` - Regional Anesthesia in Total Hip and Knee Arthroplasty	Phase 4
Completed	`NCT02876120` - The STavanger osteoARThritis Study	N/A
Terminated	`NCT02231567` - Neurocognitive Rehabilitation After Hip Replacement	N/A
Recruiting	`NCT02174965` - Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene	N/A
Completed	`NCT01506024` - Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results	N/A
Active, not recruiting	`NCT04070027` - Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With Hip Osteoarthritis	N/A
Withdrawn	`NCT04421196` - Opioid-free Total Hip Arthroplasty	N/A
Not yet recruiting	`NCT05960903` - Patient Satisfaction After Primary THA In Assiut University
Completed	`NCT04084704` - A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis	N/A
Not yet recruiting	`NCT04018690` - Project Arthritis Recovering Quality of Life Through Education - Hip	N/A
Completed	`NCT03648060` - Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement	N/A
Recruiting	`NCT05497349` - Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis	N/A
Active, not recruiting	`NCT04879732` - RSA - ACTIS Hip Stem	N/A
Active, not recruiting	`NCT05142462` - Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup
Recruiting	`NCT04665908` - PT-led Triage for Patients With Hip o Knee Osteoarthritis	N/A
Completed	`NCT04648956` - Arabic Version of the ICOAP Questionnaire
Recruiting	`NCT05465096` - Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.	N/A
Completed	`NCT02884531` - Patient Education and Basic Body Awareness Therapy in Hip Osteoarthritis: a Randomized Controlled Trial	N/A
Completed	`NCT03031314` - Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients	N/A