This study aims to improve the first phase of rehabilitation after THA. The primary objective is to analyse the effect of feedback to the patients. The secondary objective is to quantify the weight bearing in the early phase after THA surgery.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameters are generated by the SensiStep system:
- Loading rate
- The number of steps per time unit
- The number of Periods of Dynamic Loading, PDL
Secondary outcome
N.A.
Background summary
Total Hip Arthroplasty (THA) is a common surgical procedure for treatment of
coxarthrosis. Rehabilitation after such a procedure is hampered by the absence
of good quality data on the rehabilitation process, in other words, there is no
instrument available to measure the progress of rehabilitation. The SensiStep
system is an ambulant monitoring system that is used to register pressure data
under the heel. The aim of this pilot study is to detect the postoperative
weight bearing after THA. Using the feedback of the data generated by the
SensiStep system to the patient, the changes in the postoperative weight
bearing will be analyzed. These data will be used to calculate the sample size
for a bigger RCT, but as no such data are yet available, this pilot study is a
first step. Results of this study could affect other patient groups after
elective orthopedic surgery, as well as after fractures of the lower extremity.
Study objective
This study aims to improve the first phase of rehabilitation after THA. The
primary objective is to analyse the effect of feedback to the patients. The
secondary objective is to quantify the weight bearing in the early phase after
THA surgery.
Study design
In this randomised study, all patients will be monitored after THA using the
SensiStep system. Randomisation will determine which patients will recieve
feedback during weight bearing. Monitoring will take place at day 1,2,3, and 4
postoperative during the admission, and at weeks 6 and 12 in the outpatient
clinic.
Intervention
Weight bearing is registered in both study groups with the SensiStep system. In
the intervention group, direct feedback will be given during the weight bearing
using a wrist device. Using this device, patients can adjust the amount of
weight bearing.
Study burden and risks
During the regular practice sessions with the physical therapists, registration
of pressure under the sole will take place using the SensiStep system. This
will take place during the admission in the hospital at day 1,2,3 and 4
postoperative, and at weeks 6 and 12. There are no additional questionnaires or
measurements taken other than the Harris Hip Score, which is part of the
operation protocol. A risk analysis has shown no additional risk for the
patients by using the SensiStep system. Benefits are not expected within the
scope of this study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Age between 60 and 85 years
Elective surgical total hip prosthesis for coxarthrosis
Postoperative full weight bearing
Exclusion criteria
Lack of informed consent
Cognitive impairment, either pre-existent or occuring in the first day or days after surgery
Insufficient knowledge of Dutch language
Pre-opeartive comorbidity influencing the mobility other than coxarthrosis (e.g. confined to wheelchair, walking distance < 10 meters)
Complications during surgery
Weight more than 120 kg
Revision surgery
Design
Recruitment
Medical products/devices used
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 | NL49553.041.14 |