Our hypothesis is that CAC can achieve a pain-reducing effect of at least 20% after 7 days.
ID
Bron
Verkorte titel
Aandoening
Patients with painful osteoarthritis of the knee who present themselves at the orthopedic outpatient clinic of Zuyderland Medical Centre, loction Sittard-Geleen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To determine the effect of CAC on pain sensation and consumption of equianalgesics upto 7 days postoperative after TKA. Pain measured with a Numerical Rating Scale (NRS)
Achtergrond van het onderzoek
Even though some studies show excellent results regarding CAC, this treatment, the quality of the available literature is not convincing and level I evidence is still missing. Cryotherapy was generally safe and not associated with any serious adverse events and may improve the range of motion at the knee in the first one to two weeks after surgery. No studies were found that looked at the effects of cryotherapy on a person’s activities related to knee function. Well designed randomised trials are required to improve the quality of the evidence
Doel van het onderzoek
Our hypothesis is that CAC can achieve a pain-reducing effect of at least 20% after 7 days.
Onderzoeksopzet
pre- and 7 days and 2 and 6 weeks post-operatively
Onderzoeksproduct en/of interventie
The patients will be discharged to home after TKA on the day of surgery. At home the joint, will be cooled using CAC during a period of 7 days according to our protocol. Patients will receive 6 hours of continuous cooling at 8°C immediately after surgery (starting in their room). In the evening (12°C) and during the first night at home (12°C), patients will receive 4 hours each of CAC.
The day after surgery the protocol consisted of 2 hours of treatment in the morning (10°C), followed by 2 hours of CAC in the afternoon (10°C). During the second evening and nights, patients will receive one session of 4 hours each (12°C). The next nights patients are allowed to use CAC as option in case of extreme pain (12°C). The second day postoperative the protocol consisted of 2 hours of treatment in the morning (10°C), followed by by 2 hours of CAC in the afternoon (10°C), this schedule will be repeated up to postoperative day 7. The night sessions are optional in case of extreme pain (12°C). A minimum of 2 hours must be wihtin the sessions.
Algemeen / deelnemers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Wetenschappers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
•Patients scheduled to undergo primary TKA replacement
•No previous surgery on the operated knee except open meniscectomy
•Ability and willingness to follow instructions and to return for follow-up evaluations
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
•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
•Rheumatoid arthritis
•Extension deficit of more than 15 degrees
•Flexion less than 110 degrees.
•Non-correctable varus axis
•Cruciate ligament insufficiency
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5431 |
NTR-old | NTR5565 |
CCMO | NL54641.096.15 |
OMON | NL-OMON42616 |