Determining differences in postoperative swelling of the leg by the use of postoperative compression bandage of the leg versus a control group with no bandage at all, after primary THA by ASI approach. The length of hospital stay and the occurrence…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative swelling of the upper and lower leg measured at multiple moments:
before and immediately after mobilization during hospitalization, and at 7 and
14 days after surgery on the outpatient clinic. Mobilization occurs 6 hours
after surgery and from the first day postoperative twice a day until discharge.
Swelling of the leg is defined as the difference in circumference of the leg in
centimeters, compared to the preoperative circumference of the leg, measured at
2 standardized points.
Length of hospital stay.
Secondary outcome
Occurrence and amount of wound leakage.
Occurrence of wound infection.
Background summary
In Reinier de Graaf Groep (RdGG) the Anterior Supine Intermuscular technique
(ASI) is used for total hip arthroplasty (THA) procedures. This technique will
allow the patient to mobilize much earlier postoperatively compared to other
techniques. Postoperative swelling of the leg could hinder this early
postoperative mobilization. Therefore, this study will investigate the effect
of compression bandage on the postoperative swelling of the leg after primary
THA by ASI technique.
Study objective
Determining differences in postoperative swelling of the leg by the use of
postoperative compression bandage of the leg versus a control group with no
bandage at all, after primary THA by ASI approach. The length of hospital stay
and the occurrence and amount of wound leakage and the occurrence of wound
infection will be measured also.
Study design
This study is a randomized, controlled trial comparing the outcome in one group
of interest, the total hip arthroplasty group, using postoperative compression
bandage of the leg versus a control group with no bandage at all.
Patients with osteoarthritis of the hip, who qualify for a primary THA by ASI
approach, will be randomized into 2 groups. Group 1 will be given a compression
bandage for 24 hours. Group 2 (control group) will be given no bandage at all.
Intervention
not applicable
Study burden and risks
Patients will receive their planned THA. There will be some extra clinical
control moments to measure the circumference of the leg. This will be
immediately after mobilization, at 4-6 h after surgery and from day 1
postoperatively twice a day until discharge, and at the standard control moment
14 days after surgery.
There will be 1 extra control moment after discharge when compared to normal
THA patients. This will be 7 days after surgery for measuring the circumference
of the leg as well.
Reinier de Graafweg 3-11
Delft 2625AD
NL
Reinier de Graafweg 3-11
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed for THA by ASI approach for osteoarthritis.
Aged 18 and older.
Exclusion criteria
Mentally retarded.
BMI > 35
Participating in another study.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL44038.098.13 |