Trial Description Title Evatuation of long-term biomechanical effects of an elastic knee sleeve in subjects with moderate to severe medial knee osteoarthritis Trial Acronym [---]* URL of the trial [---]* Brief Summary in Lay Language This study tests if wearing an elastic knee sleeve for 8 weeks influendes gait characteristics in subjects with medial knee osteoarthritis. Prior studies have shown that the acute effect of a knee sleeve was reduced knee adduction during gait. A subsequent longitudinal study confirmed this tendency but failed to reach statistical significance. In the present study, the inclusion criteria for subject have been narrowed in order to prevent those subjecs from participating who, even without a sleeve, have little or no functional impairment and therefore presumably cannat benefit from a sleev. Subject undergo a pre and post test where gait characteristics and joint proprioception are assessed with biomechanical tests with and without the sleeve. Between these two tests, there is an 8 week period during which subjects of the intervention grour are supposed to wear the sleeve at least 6 hours each day. Subjects of the control group must not wear a sleeve during this time. Brief Summary in Scientific Language Osteoarthritis of the knee causes pain and impairs function of the respective joint. The consequence is an impairment of gait kinematics and neuromascular activation of the whole body and specifically the lower extremity (Block & Shakoor, 2010; Ornetti et al., 2010). A prior study at the Department of Sport Sciece of the University of Freiburg showed that wearing an elastic knee sleeve immediately influenced gait kinematics and kinetics (Schween et al., in prep.; Ethics vote No. 107/12). Based on these results, a subsequent longitudinal study tested if the observed effects would prevail during an 8-weeks intervention (184/13). Gait kinematics and kinetics were assessed in subjects with unilateral knee osteoarthritis in a pre and post measurement. The focus was on the frontal plane. The results showed tendencies in the same direction as the effects found by Schween et al. (in prep.). Specifically, the knee adduction moment was reduced by an average of 5%. However, these tendencies failed to reach statistical significance. A retrospective view of the two prior studies at our department indicates that the effects of a knee sleeve depend strongly on the individual impairment of knee function in general and knee function in the test situation in particular. More specifically: the longitudinal study inlcuded several subjects that showed no or little functional impaiment during baseline-testing without a knee sleeve already. We reason that the knee sleeve could not have further improved pain or function in these subjects in the test situation. Therefore, we keep the Page 1 of 6
hypothesis that a knee sleeve can improve function, and particularly lateral differences in gait biomechanics, over a longer period. The aim of the current study therefore is to again test whether the effects found by Schween et al. (in prep.) prevail during an 8-weeks intervention. Based on experience from the earlier longitudinal study, we try to reduce the floor-effect described above by narrowing the inclusion criteria for the sleeve. Specifically, we want to prevent subjects from participating that show no or little functional impairment at baseline. Organizational Data DRKS-ID: DRKS00006126 Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 213/14, Ethik-Kommission der Albert-Ludwigs- Universität Freiburg Secondary IDs Universal Trial Number (UTN): U1111-1156-0412 Sponsor-ID: [---]* Health condition or Problem studied Free text: osteoarthritis ICD10: M17 - Gonarthrosis [arthrosis of knee] Interventions/Observational Groups Arm 1: Arm 1: Intervention group. Subjects age 30-67 with diagnosed (preferentially) medial osteoarthritis of the knee. Kinematics, Kinetics and neuromuscular control are tested in pre- and post measurements in several conditions: walking, running, stair climbing, stair descending, each with and without the knee sleeve. Relevant personal and disease-related data are assessed by questionnaires. Subjects are subsequently asked to wear the knee sleeve for 6 at least 6 hours/day and during all physical activity for 8 weeks. Subjects are provided with information about the sleeve at the first measurement and through an information sheed. Arm 2: Arm 2: Control group. Subjects age 30-67 with diagnosed (preferentially) medial osteoarthritis of the knee. Kinematics, Kinetics and neuromuscular control are tested in pre- and post measurements in several conditions: walking, running, stair climbing, stair descending, each with and without the knee sleeve. Relevant personal and disease-related data are assessed by questionnaires. During the 8-weeks-intervention, subjects are asked to not wear any kind of knee sleeve. Page 2 of 6
Arm 2: Arm 2: Control group. Subjects age 30-67 with diagnosed (preferentially) medial osteoarthritis of the knee. Kinematics, Kinetics and neuromuscular control are tested in pre- and post measurements in several conditions: walking, running, stair climbing, stair descending, each with and without the knee sleeve. Relevant personal and disease-related data are assessed by questionnaires. During the 8-weeks-intervention, subjects are asked to not wear any kind of knee sleeve. Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: [---]* Control: Active control Purpose: Basic research/physiological study Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome After 8 week knee support the reduction of knee joint load will be compared to a no-treatment control group. Knee joint load is determined by kinematic and kinetic parameters (adduction, adduction moment, joint stiffness) Knee joint controll is determined of muscles surrounding the joint (electromyography) and an additional angle reproduction test. Secondary Outcome After 8 week knee support changes in subjective pain will be compared to a notreatment control group. Changes in subjective pain will be investigated in relation to changes in knee joint load. Countries of recruitment DE Locations of Recruitment Page 3 of 6
University Medical Center Klinik für Orthopädie und Unfallchirurgie, Freiburg im Breisgau Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2014/05/20 Target Sample Size: 40 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 30 Years Maximum Age: 67 Years Additional Inclusion Criteria Male and female subjects, medically diagnosed moderate to severe (preferably) medial knee osteoarthritis (Kellgren-Lawrence Grade >2) and pain dominantly in the medial compartment (visual analog scale). Static varus alignment of the knee. Age between 30-67. Exclusion criteria Disability to go or to run contingent on health problems, neurological diseases, artificial ankle, knee or hip joint, knee support during last 6 months. Addresses Primary Sponsor Institut für Sport und Sportwissenschaft der Albert-Ludwigs-Universität Freiburg Mr. Prof. Dr. Albert Gollhofer Schwarzwaldstraße 175 79117 Freiburg Telephone: +49 761 203-4510 Fax: +49 761 203-4534 E-mail: albert.gollhofer at sport.uni-freiburg.de URL: [---]* Contact for Scientific Queries Page 4 of 6
Contact for Scientific Queries Institut für Sport und Sportwissenschaft der Albert-Ludwigs-Universität Freiburg Mr. Raphael Schween Schwarzwaldstraße 175 79117 Freiburg Telephone: +49 761 203-4529 Fax: +49 761 203-4534 E-mail: raphael.schween at sport.uni-freiburg.de URL: [---]* Contact for Public Queries Institut für Sport und Sportwissenschaft der Albert-Ludwigs-Universität Freiburg Mr. Raphael Schween Schwarzwaldstraße 175 79117 Freiburg Telephone: +49 761 203-4529 Fax: +49 761 203-4534 E-mail: raphael.schween at sport.uni-freiburg.de URL: [---]* Sources of Monetary or Material Support Commercial (pharmaceutical industry, medical engineering industry, etc.) Bauerfeind AG Mr. Dr. Uwe Berendt Triebeser Straße 16 07937 Zeulenroda-Triebes Telephone: +49 36628-66 1720 Fax: +49 36628-66 1718 E-mail: uwe.berendt at bauerfeind.com URL: www.bauerfeind.com Status Recruitment Status: Recruiting stopped after recruiting started Study Closing (LPLV): 2014/12/16 Page 5 of 6
Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 6 of 6