The effect of Computer-assisted Cryotherapy (CAC) on pain and narcotic consumption after TKA A prospective dubbel blind randomized controlled study

Completed

Conditions: Post operative pain and narcotic consumption
10023213

Registration Number: NL-OMON42616

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain sensation of the operated joint, measured with a Numerical Rating Scale<br /><br>(NRS, 0 to 10, 10 being worst pain), before TKA and daily on fixed time<br /><br>points in a Pain diary including analgesic use measured as tramadol consumption<br /><br>as equianalgesic amounts. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Knee range of motion (ROM), measured as degrees of active knee flexion and<br /><br>extension evaluated with the use of a handheld goniometer.<br /><br>* Swelling (measured as circumference in millimeters at two fixed points of the<br /><br>knee at the same time of day at different stages postoperatively, 10 cm<br /><br>superior to the patella and 10 cm inferior to the patella and then the average<br /><br>was divided by two and expressed in millimeters)<br /><br>* Visual hematoma (yes/no)<br /><br>* Patient reported outcome measures (PROMS) including WOMAC and Oxford Knee<br /><br>Score. Furthermore, quality of life will be assessed with the EuroQoL-5D<br /><br>questionnaire. </p><br>