The goal of this study is to measure the amount of movement of the knee prosthesis in relation to the bone with the use of the Comforthod system. So an objective discrimination can be made whether a prosthesis is loose or fixed.
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
Synonym
Health condition
Knie prothese
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of this study is the amount of movement of the
prosthesis relative to adjacent bone. The amount of movement is expressed in
movement in the screw axis, rotation of the prosthesis and movement in the x, y
and z plane.
These outcomes will be compared with the findings of the standard care pathway
and the findings during revision surgery.
The amount of movement of the prosthesis relative to the adjacent bone as
measured in asymptomatic patients will be compared to amount of movement found
by Comforthod system in patients were the TKA was found to be loose
intra-operatively.
Secondary outcome
Secondary outcome measure is the difference between the two groups in the
amount of prosthesis movement with the
adjacent bone. The amount of movement is expressed in movement in the screw
axis, rotation of the prosthesis and
movement in the x,y and z axis.
Background summary
Total Knee Arthroplasty (TKA) is a highly effective treatment for pain and loss
of function caused by rheumatoid arthritis or osteoarthritis of the knee. The
utilization of TKA has increased significantly over the last years. Although
TKA is a very successful surgical procedure showing satisfactory results,
failure does occur and results in persistent knee pain. The main cause for
revision after TKA is aseptical loosening. The technique to diagnose TKA
loosening remain unspecific. It is a combination of tests that can only detect
secondary effects of prosthesis loosening and the clinical suspicion that can
be made by physical examination. Altogether the diagnostic process can last six
months and most often ends in a diagnosis of loosening with only 70-75%
sensitivity and specificity.
Study objective
The goal of this study is to measure the amount of movement of the knee
prosthesis in relation to the bone with the use of the Comforthod system. So an
objective discrimination can be made whether a prosthesis is loose or fixed.
Study design
This clinical diagnosing study evaluates the use of Comforthod system compared
to the gold-standard diagnostic tool for loosening of the prosthesis.
This study will take place with patients that are scheduled for revision
surgery because of clinical suspicion for aseptic loosening.
Study burden and risks
All patients in this study will undergo an extra examination. The examination
consist of the use of the Comforthod system in combination with a CT-scan in
which a radiation doses of 1.2 mSv will be inflicted to the lower limb. The
maximum force that the Comforthod system inflicts to the lower limb is 20 Nm.
The 20 Nm is less than the daily forces a leg with a knee prosthesis will
endure. With this knowledge the expectation is that the use of the Comforthod
system will not bring an extra burden or risk to the patient.
The benefit for this study population is that this will be the first time that
a direct diagnosing tool will be used to determine whether a knee prosthesis is
fixed or loose. The outcomes of this study could possibly contribute to reduced
length and lower costs of the diagnosing process for aseptical loosening of a
TKA.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
-Patients diagnosed with aseptic loosening of the knee prosthesis and that are
scheduled for revision surgery.
- Patients with a TKA who are asymptomatic and have no complaints oftheir knee
prosthesis.
- Patients capable of giving informed consent and are willing to do this extra
examination
Exclusion criteria
- Patients with another cause for revison surgery besides aseptic loosening.
- Patients who are unable or unwilling to sign the informed consent for this
study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49757.018.14 |