Gait symmetry of patients with an endoprosthetic reconstruction of the knee joint after bone tumour resection.

Gait symmetry of patients with an endoprosthetic reconstruction of the knee joint after bone tumour resection. - Gait symmetry with a knee endoprosthesis after tumour resection

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52588

Enrollment

Registered

2019-10-24

Start date

2019-11-01

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

bone cancer bone tumour

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Tumour resection and a reconstruction of the knee joint with a MUTARS® system (Modular Universal Tumour and Revision System) in the LUMC during the previous 10 years (2008-2018) due to a primary bone tumour around the knee (distal femur or proximal tibia); Tumour resection and reconstructive surgery is at least 1 year ago; One unaffected (healthy) leg; Normal or corrected to normal vision; At least 18 years old at time of inclusion; Signed informed consent form.

Exclusion criteria

Exclusion criteria: Major revision surgery (e.g. total replacement of the prosthesis with reattaching muscles) in the last 1 year; Minor revision surgery (e.g. replacement of a small part of the prosthesis without reattaching muscles) in the last 3 months; Endoprosthetic failure; Comorbidities interfering with gait function Inability to comply with the assessment in the TIM laboratory; Inability to walk independently.

Design outcomes

Primary

Measure	Time frame
Measurements are performed in two gait labs. Part of this amendment is the addition of a second gait lab. Gait Laboratory 1 is the Technology in Motion (TIM) lab at the LUMC. We use the interactive walkway. The interactive walkway makes it possible to record movements without sensors. Gait laboratory 2 is the movement lab for rehabilitation medicine at the LUMC. The M-Gait treadmill, a treadmill with multiple calibrated camera setup and bilateral continuous ground reaction force measurement, was introduced in 2022. The participant first walks in lab 1 and then in lab 2. Measurements - Step time (s) during unperturbed comfortable walking for the affected leg and the unaffected leg measured with the Interactive Walkway. Step time is the time interval between initial contact of one leg to the consecutive initial contact of the contralateral leg; - Interlimb step time difference (s) to quantify for (a)symmetry; - Patient reported outcome scores (PROM's) for pain, fear (kinesiophobia) and health using a numeric rating scale (NRS) administered before gait analysis. For measurements on the treadmill, the participant will be secured in a CE-approved harness that is secured to the ceiling with ropes under dynamic pretension. For measurements with the M-Gait the subjects will walk on the treadmill for one-and-a-half minute twice: once with the mean walking velocity measured earlier with the IWW, in order to maximize the comparability with data obtained with the IWW, and once using self-paced mode, where the treadmill speed is automatically adapted to the patients walking speed. For both measurements, the patient will be able to get familiar with walking on the treadmill for the first 30 seconds and only the last minute of walking will be recorded and used for analysis.	—

Measure

Time frame

Measurements are performed in two gait labs. Part of this amendment is the addition of a second gait lab. Gait Laboratory 1 is the Technology in Motion (TIM) lab at the LUMC. We use the interactive walkway. The interactive walkway makes it possible to record movements without sensors. Gait laboratory 2 is the movement lab for rehabilitation medicine at the LUMC. The M-Gait treadmill, a treadmill with multiple calibrated camera setup and bilateral continuous ground reaction force measurement, was introduced in 2022. The participant first walks in lab 1 and then in lab 2. Measurements - Step time (s) during unperturbed comfortable walking for the affected leg and the unaffected leg measured with the Interactive Walkway. Step time is the time interval between initial contact of one leg to the consecutive initial contact of the contralateral leg; - Interlimb step time difference (s) to quantify for (a)symmetry; - Patient reported outcome scores (PROM's) for pain, fear (kinesiophobia) and health using a numeric rating scale (NRS) administered before gait analysis. For measurements on the treadmill, the participant will be secured in a CE-approved harness that is secured to the ceiling with ropes under dynamic pretension. For measurements with the M-Gait the subjects will walk on the treadmill for one-and-a-half minute twice: once with the mean walking velocity measured earlier with the IWW, in order to maximize the comparability with data obtained with the IWW, and once using self-paced mode, where the treadmill speed is automatically adapted to the patients walking speed. For both measurements, the patient will be able to get familiar with walking on the treadmill for the first 30 seconds and only the last minute of walking will be recorded and used for analysis.

—

Secondary

Measure	Time frame
- Toronto Extremity Salvage Score (TESS), lower extremity version: a validated questionnaire to assess patient-reported physical outcome; - Pedometer-assessed (health app, mobile phone) steps per day, if available, of the last week for assessing the daily physical activity; - Other walking data recorded in the TIM-lab can be used for possible sub analyses: centre of body mass, gait speed, step width, step length, stride time, turning time, stride length, cadence.	—

Measure

Time frame

- Toronto Extremity Salvage Score (TESS), lower extremity version: a validated questionnaire to assess patient-reported physical outcome; - Pedometer-assessed (health app, mobile phone) steps per day, if available, of the last week for assessing the daily physical activity; - Other walking data recorded in the TIM-lab can be used for possible sub analyses: centre of body mass, gait speed, step width, step length, stride time, turning time, stride length, cadence.

—

Countries

Netherlands

Outcome results