To assess the effect of CAC with effective temperature on pain sensation and consumption of narcotics in patients operated for TKA after 7days postoperative compared to CAC without effective temperature.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain sensation of the operated joint, measured with a Numerical Rating Scale
(NRS, 0 to 10, 10 being *worst pain*), before TKA and daily on fixed time
points in a Pain diary including analgesic use measured as tramadol consumption
as equianalgesic amounts.
Secondary outcome
* Knee range of motion (ROM), measured as degrees of active knee flexion and
extension evaluated with the use of a handheld goniometer.
* Swelling (measured as circumference in millimeters at two fixed points of the
knee at the same time of day at different stages postoperatively, 10 cm
superior to the patella and 10 cm inferior to the patella and then the average
was divided by two and expressed in millimeters)
* Visual hematoma (yes/no)
* Patient reported outcome measures (PROMS) including WOMAC and Oxford Knee
Score. Furthermore, quality of life will be assessed with the EuroQoL-5D
questionnaire.
Background summary
External application of cold therapy in the proximity of joints is an old but
poorly investigated treatment modality for postoperative pain. It has been
shown that it can decrease swelling and can thus possibly reduce local pain
sensation. Despite all that, on closer consideration the universally valid
consensus of the optimal methods regarding locally applied cryotherapy after
TKA is still clearly missing. Therefore, we will investigate the effect of
locally applied Computer-assisted Cryotherapy (CAC) on pain sensation and
consumption of narcotics in patients who are operated for total knee
arthroplasty (TKA) following an outpatient surgery pathway. These patients will
be discharged on the day of surgery, and will have theyre own CAC-system at
home.
Study objective
To assess the effect of CAC with effective temperature on pain sensation and
consumption of narcotics in patients operated for TKA after 7days postoperative
compared to CAC without effective temperature.
Study design
Prospective, randomized placebo controlled trial with two arms:
* arm 1: CAC with effective temperature
* arm 2: CAC without effective temperature
Intervention
CAC of the operated knee, given on post operative day 0 upto day 7with or
without effective temperature
.
Study burden and risks
Cryotherapy was generally safe and not associated with any serious adverse
events.
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
-Patients scheduled to undergo primary TKA replacement with any of the following indications
-Painful and disabled knee joint resulting from osteoarthritis.
-High need to obtain pain relief and improve function,
-Above 18 years old.
-Body-mass-index (BMI) <35
-Ablility and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
-Consent form read, understood and signed by patient.
Exclusion criteria
-Active infection in knee
-General infection
-Distant foci of infections which may spread to the implant site
-Failure of previous joint replacement
-Pregnancy
-Previous major knee surgery, except for arthroscopic meniscectomy.
-Metal near knee joint (MRI-scan not possible)
-Not able or willing to undergo MRI-scan or CT-scan
-Reumatoid arthritis
-Non-correctable varus axis
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL54641.096.15 |
| OMON | NL-OMON23301 |