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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42616
Enrollment
60
Registered
2015-10-07
Start date
2015-10-27
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post operative pain and narcotic consumption

Interventions

CAC of the operated knee, given on post operative day 0 upto day 7with or without effective temperature .

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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)

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
* 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)