M17.0 M17.1 M17.4 M17.3
Conditions
Interventions
Group 1: Single bout of exercise therapy and wearing an unloader brace
Group 2: Single bout of exercise therapy and wearing an placebo brace
Sponsors
Abteilung Sportmedizin, Goethe-Universität Frankfurt am Main
Goethe-Univrsität Frankfurt am Main
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Medial (varus) osteoarthritis Kellgren-Lawrence grade II to IV (lateral osteoarthritis & PF osteoarthritis: 0-I°), primarily one knee 3. Current (day maximum) knee pain of >30 mm on a 0-100 mm VAS scale during motion 4. Varus knee alignment 2 – 10° 5. BMI < 35 kg/m2
Exclusion criteria
Exclusion criteria: 1. Ligament instability, knee flexion contracture > 15° (compared to the contralateral knee), overall limited mobility (Charnley class C) 2. History of knee, tibial or femoral surgery or fracture, history of hip or ankle joint osteoarthritis 3. Current musculoskeletal injuries/complaints except unilateral knee osteoarthritis 4. Cardiovascular / neurologic diseases or impairments / diabetes / rheumatoid, inflammatory , or neuropathic arthritis 5. History of previous large radiation exposure 6. Current pregnancy 7. Knee injection within the previous 12 months. 8. Septic arthritis, bone metabolic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee joint acoustic emissions. Assessed by means of two high-performance, low power, top port silicon microphones with a diameter of 3 cm and a depth of 1 cm (SPU0414HR5H-SB; Knowles Electronics, LLC. Itasca, IL, USA). Outcomes: Amplitude and Mean power frequency. | — |
Secondary
| Measure | Time frame |
|---|---|
| Crossover-part: Impact of the unloader (in contrast to the placebo) on all outcomes du - Muscle activity: mean power frequency and amplitude - Knee kinematics: Absolute and relative ranges of motion (ROMs) [°] and angle velocities [°/sec] - Self-reported functional limitations, pain, and pain associated discomfort - Gait characteristics Gait speed [m/s], cadence [steps/min], double stride length [cm], step width [cm], foot external/internal rotation [°], hind- and forefoot plantar pressure [N/cm2], stance and stride times, swing phases, as well as single and double limb support durations - Foot-ground-interaction is used for balance (center of pressure, mm), peak ground reaction forces [N/cm2], hind- and forefoot plantar pressure relations [N/cm2], and for dynamic balance assessment, calculated as time to stabilization (TTS bw [s]). In the prospective cohort study-part, patients fill in an exercise log to monitor training compliance.Type, time, duration, level, intensity, and frequency will be monitored. Further, potential discomfort, and other potential barriers will be, likewise, prospectively monitored. Here, by means of a standardized/structured interview, further chances and barriers of wearing the unloader during both activities of all-daily living and exercises will be assessed. All participants further complete questionnaires (SF-36, KOOS) to display potential long-term benefits. | — |
Countries
Germany
Contacts
Public ContactDaniel Niederer
Abteilung Sportmedizin und Leistungsphysiologie; Goethe-Universität Frankfurt
Outcome results
None listed