Prevention of Post-Traumatic Osteoarthritis (OA)

Pathogenesis-Prevention of Post-Traumatic Osteoarthritis (OA): Effects of Distraction and Motion on OA

Sponsoren

Hauptsponsor: Ned Amendola

Mitarbeiter: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Quelle University of Iowa
Kurze Zusammenfassung

Joint injury and trauma dramatically increase the risk of developing osteoarthritis (OA). The purpose of this study is to determine what factors lead to decreased pain, improved joint function, and repair of the joint surface in post-traumatic OA.

Study hypotheses: 1) Ankle motion during distraction will result in clinically significant improvements in Ankle Osteoarthritis Scale scores, SF-36 scores, and improved cartilage thickness distribution over the habitually most heavily loaded portion of the articular surface, as compared to the use of distraction without ankle motion. 2a) Ankles with low geometric surface irregularity and greater range of motion will have better preservation of neo-chondroid tissue (increased normalized cartilage thickness and reduced longitudinal compressive strain in the habitually heavily regions of the articular surface) than those with high surface irregularity. 2b) Low geometric surface irregularity and greater range of motion will have reduced habitual focal or regional contact stress elevation. 3) Joints that have better improvements in Ankle Osteoarthritis Scale scores and improved cartilage thickness distribution over habitually heavily loaded portion of the articular surface will have improved normalization of synovial fluid markers of biosynthetic/degradative activity and oxidative stress.

detaillierte Beschreibung

Little work has been done on the pathogenesis and prevention of post-traumatic OA. The human ankle joint provides a unique opportunity for the study of post-traumatic OA because of the low risk of primary OA and the relatively high risk of post-traumatic OA. This study involves a multidisciplinary approach utilizing both laboratory and clinical research to improve understanding of OA and to develop innovative approaches for preventing and treating this disease. Mechanical distraction involves operative placement of specialized pins and rods to hold the joint in place. Some distraction allows for limited motion of the joint, while other distraction holds the joint immobile. The purpose of this study is to elucidate the mechanical factors that lead to restoration of a cartilaginous articular surface, decreased pain, and improved joint function after mechanical distraction of osteoarthritic joints.

Participants in this study will be randomly assigned to one of two treatment groups. Group A will be treated with mechanical distraction with motion; Group B will be treated with mechanical distraction without motion. Participants will be followed for 28 months and will have 11 study visits. Most of the study visits will occur during the first half of the study. State-of-the-art techniques for clinical assessment, articular surface imaging, biomechanical modeling, and biochemical testing will be used in this study.

Gesamtstatus Completed
Anfangsdatum November 2002
Fertigstellungstermin February 2009
Primäres Abschlussdatum February 2009
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Ankle Osteoarthritis Scale scores Two years
CT data to measure cartilage distribution over the articular surface and synovial fluid markers of biosynthetic/degradative activity and oxidative stress in response to treatment and comparison to clinical and radiographic changes Two years
Improved joint function Two Years
Einschreibung 40
Bedingung
Intervention

Interventionsart: Procedure

Interventionsname: Ankle distraction permitting motion

Beschreibung: External fixator is applied to ankle joint for 85 - 95 days; ankle motion is permitted

Armgruppenetikett: Group A

Interventionsart: Procedure

Interventionsname: Ankle distraction without motion

Beschreibung: External fixator is applied to ankel joint for 85 - 95 days; ankle motion is not permitted

Armgruppenetikett: Group B

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Symptomatic isolated ankle OA (unilateral Kellgren grade 3, 4, or 5)

- Skeletally mature (children included if they have no open growth plates)

- Failure of less than 1 year nonoperative treatment, including 3 months of continuous treatment with nonsteroidal anti-inflammatory agents and 3 months of unloading treatment (i.e., unloading brace, crutches, cane, walker)

Geschlecht: All

Mindestalter: N/A

Maximales Alter: 60 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Ort
Einrichtung: Department of Orthopedics and Rehabilitation, University of Iowa
Standort Länder

United States

Überprüfungsdatum

March 2017

Verantwortliche Partei

Art: Sponsor-Investigator

Ermittlerzugehörigkeit: University of Iowa

Vollständiger Name des Ermittlers: Ned Amendola

Ermittlertitel: Professor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Group A

Art: Experimental

Beschreibung: Group A participants will be treated with mechanical distraction with motion

Etikette: Group B

Art: Active Comparator

Beschreibung: Group B participants will be treated with mechanical distraction without motion

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Prevention

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov