Shoe adaptation for patients with osteoarthritis in the ankle after ankle fracture

Completed

Conditions: Post-traumatic ankle arthritis
Musculoskeletal Diseases

Registration Number: ISRCTN85568283

Lead Sponsor: niversity Medical Centre Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 16

Inclusion Criteria

1. Age = 18 years
2. Fracture of tibia, fibula or talus in medical history
3. Daily ankle and/or foot pain with a NRS score at baseline > 3
4. Radiological evidence for osteoarthritis in tibial-talar joint
5. Being able to walk at least 100 meters without any support
6. Signed informed consent

Exclusion Criteria

1. Concomitant conditions like cardiovascular disease or neuromuscular disease or musculo-skeletal problems in other joints that intervene with walking
2. Ankle arthrodesis or arthroplasty in place
3. Other forms of osteoarthritis (e.g., primary osteoarthritis, OA secondary to rheumatoid arthritis or haemophilia)
4. Leg length difference of more than 2 cm
5. Planned activities within the research period, like holiday, that influence the normal level of activity
6. Limited ankle motion in rest, defined as total passive ROM (range of motion) < 10°

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Primary biomechanical outcome: range of motion (sagittal) in ankle during stance phase. The ROM was calculated by adding the maximum dorsal flexion during stance phase to the maximum plantar flexion from the early stance phase<br>2. Primary clinical outcome: pain score, reported by patients using numeric rating scale scoring (0-10). Patients kept a diary for the whole 6 weeks (so including washout), for recording the daily average pain and the daily maximum pain

Secondary Outcome Measures

Name	Time	Method
Secondary biomechanical outcomes: sagittal ankle moments (Nm/kg), step length (m), speed (m/s), cadence (steps/min) and stance time (s). The biomechanical parameters were measured using the VICON system. Sixteen reflective markers were placed bilaterally on anatomical landmarks according to the lower body Plug-in-Gait model of Vicon. The markers were tracked by an eight-camera motion capture system (Vicon, Oxford, UK, fs = 100 Hz) to measure the kinematics. Force data were measured by force plates (AMTI; Watertown, Massachusetts, fs = 1000 Hz). Joint kinematics and kinetics were computed using VICON Nexus software and further processed using MatLab.