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Conservative Therapy of medial Osteoarthritis of the Knee: Comparison of an ankle-foot-orthosis with lateral wedge insoles in a cross-over study

Conservative Therapy of medial Osteoarthritis of the Knee: Comparison of an ankle-foot-orthosis with lateral wedge insoles in a cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016783
Enrollment
50
Registered
2019-02-26
Start date
2018-05-16
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M17.9

Interventions

Group 1: 6 weeks ankle-foot orthosis "Agilium Freestep" (Ottobock), then 6 weeks laterally wedged insole Group 2: 6 weeks laterally wedged insole, then 6 weeks ankle-foot-orthosis (AFO) "Agilium Frees

Sponsors

Universitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Primary and secondary osteoarthritis of the knee (Kellgren & Lawrence 1-3), physiotherapy, oral analgetics and other external therapies as possible accompanying therapies, no history of orthosis or insoles or orthopedic shoe modifications for osteoarthritis of the knee, competency to give consent

Exclusion criteria

Exclusion criteria: history of surgery for osteoarthritis, invasive therapies (e.g. injections), Kellgren & Lawrence 4, lack of physical capacity or lack of compliance, cancellation if withdrawal of consent

Design outcomes

Primary

MeasureTime frame
Change of external knee adduction moment (KAM) and ankle biomechanics as determining factor for the change in KAM. Measurement by 3D instrumented gait analysis with each orthopedic device after 6 weeks of use of the device, compared with gait analysis without any device.

Secondary

MeasureTime frame
Changes in osteoarthritis symptoms (American Knee Society Score, Oxford 12 Knee Score and FFbH-OA: functional questionnaire of Hannover for OA) and health-related quality of life (EQ-5D) after 6 and 12 weeks compared to the beginning of the study.

Countries

Germany

Contacts

Public ContactMartin Schwarze

Universitätsklinikum Heidelberg, Klinik für Orthopädie und Unfallchirurgie

martin.schwarze@med.uni-heidelberg.de062215634717

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026