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Fast Track Recovery with Bioheat Transfer in Knee Revision-prosthesis

Fast Track Recovery with Bioheat Transfer in Knee Revision-prosthesis - Bioheat Transfer in Knee Revisions-prosthesis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36903
Enrollment
30
Registered
2012-11-13
Start date
2012-10-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

inflammation postopertive recovery

Interventions

None listed

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 18 - 90 years Implantation of a semi-constrained or constrained knee prosthesis in the course of - revision procedures as: explantation of primary total knee prosthesis or spacer explantation and implantation of semi-constrained knee prosthesis - instability (primary and secondary knee replacement) Written informed consent

Exclusion criteria

Exclusion criteria: Body Mass Index greater than 40 Cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria Acute fracture, infection or tumour at the affected knee Cold allergy or cold intolerance Raynaud's Disease Circulatory disorder at affected site (e.g. PAD, Diabetic foot) Fibromyalgia or other chronic pain syndromes Drug or alcohole abuse Pregnancy or possible pregnancy without adequate contraception No written informed consent Unsoundness of mind

Design outcomes

Primary

MeasureTime frame
Primary Objective: Increase of Flexion in the group of patients receiving cTreatment

Secondary

MeasureTime frame
Secondary Objective(s): 1.) reduced opioids consumption postoperative 2.) reduced Pain in the VAS-score 3.) reduced swelling postoperative (5th day)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)