The objectives of this study are answering these two questions:1. Do patients with KR-R show a clear and fast recovery of walking?2. Are there any other parameters that improve clearly and quickly after KR-R?
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gait parameters and directly related measurements:
- maximum walking velocity
- comfortable walking velocity
- gait kinematics
- the DynaPort KneeTest for activities of daily living (ADL).
Secondary outcome
[Independent: Demographic data, such as age, gender, weight, medical intake
(co-morbidity, co-interventions).]
Knee Society Knee Score
Scores on
questionnaires:
- the SF36 for health-related quality of life.
- the WOMAC for osteoarthritis-related quality of life
- the TAMPA scale for fear of movement
- the IPAQ for the amount of physical activity
- a question about the priority given to daily routines
- VAS-scores before and after the experiment, as to expected / experienced
pain, fatigue, anxiety
Quadriceps strength
Oxygen consumption during walking
Serum concentrations of inflammation mediators, such as IL6 and CRP.
Background summary
Currently, 300,000 Dutch residents suffer from knee OA, with a total of 7,500
Total Knee Replacement (TKR) performed yearly (Lenssen et al., 2006). In view
of the ageing of the population, these numbers are expected to increase. TKR is
often regarded as a successful procedure to relieve pain and restore function.
Still, functional recovery after Knee Replacement (KR) is slow, and some
patients continue to have problems, e.g., slow walking. In our group, we have
much experience with the study of walking recovery after TKR. Informal
experience suggests that walking recovery after TKR with the ROCC (KR-R) is
unusually fast.
Study objective
The objectives of this study are answering these two questions:
1. Do patients with KR-R show a clear and fast recovery of walking?
2. Are there any other parameters that improve clearly and quickly after KR-R?
Study design
A prospective cohort study. A group of not more than 20 patients with
unilateral osteoarthritis of the knee (the "patients") will be followed from
shortly before to 6 weeks, 6 months, and, if possible, 12 months after Knee
Replacement with the ROCC (KR-R). We will measure oxygen cost of walking, gait
kinematics, quadriceps strength, and movement acceleration during daily
activities, concentrations of inflammation mediators, and patients' self-
reports: VAS- scales for pain, TAMPA for kinesiophobia, SF-36 for
health-related quality of life, WOMAC for osteoarthritis-related quality of
life, and the IPAQ for physical activity.
Study burden and risks
In the present protocol, measurements will not take longer than 3 hours per
measurement session per participant. Technically, the risks are very low. Two
researchers (one of whom with at least a paramedical education) will be present
during all measurement sessions, and during treadmill sessions participants are
secured to a harness so that falling is impossible. Patients are invited to
bring another person, we take a lot of time for personal contact, and patients
are usually very positive about their experience with us.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
age between 40 and 80, unilateral osteoarthritis of the knee, waitlisted for knee replacement with the ROCC at the Gemini Hospital in Den Helder or the Albert Schweizer Hospital in Zwijndrecht
Exclusion criteria
replacement of the other knee (earlier, scheduled, or to be scheduled), revision operation, any conditions than osteoarthritis of the knee that interfere with gait (such as neurological, skeletomuscular, or obstetric disorders), any conditions that render the patient unfit to be tested (such as pulmonary and/or cardiac disorders), any conditions that render the patient unable to understand or adhere to the protocol (such as cognitive, visual and/or language problems, or hand problems, that render the patient unfit to fill-in the questionnaires)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20287.029.07 |