Primary objective: To use 4D-CT to find possible relations between functional deficiencies of patients with an Aptis Scheker prosthesis and important prosthesis characteristics like implant placement and implant design.Secondary objective: To…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be the range of motion (ROM, pro-sup and
flex-ext), grip strength, patient reported outcome measures (PROM), the
position of the radius with respect to the ulna and the position of the axis of
rotation. The latter two will act as independent variables in a linear
regression to find out if and how they influence the first four parameters. The
main study endpoint will be to optimize implant characteristics (size,
placement, kinematic behavior) to improve wrist function.
Secondary outcome
nvt
Background summary
Evaluation of distal radioulnar prosthesis performance is not very common and
does not seem necessary since studies report that prosthesis longevity and
patient satisfaction are high (>90%)1,2 . However, the complication rate is
approximately 25% This raises the question whether patient satisfaction and
prosthesis longevity are valid indicators of prosthesis performance.
A better way to evaluate the performance on an implant is by a
quantitative comparison to the healthy contralateral joint, which can be
considered to be the gold standard. Range of motion, motion pattern and the
position of the rotational axis of the forearm are some parameters that
describe the function of the wrist quantitatively.
With the emergence of four dimensional computed tomography (4D-CT)
technology quantitative evaluation of DRUJ motion has become feasible.
Combining regular- and 4D-CT in the follow up of patients who have undergone
DRUJ arthroplasty would objectify prosthesis performance. Moreover, a
quantitative kinematic assessment may reveal limitations in the use or design
of current DRUJ prostheses and could improve future use of DRUJ prostheses.
Study objective
Primary objective: To use 4D-CT to find possible relations between functional
deficiencies of patients with an Aptis Scheker prosthesis and important
prosthesis characteristics like implant placement and implant design.
Secondary objective: To provide a 4D-CT based method for quantifying DRUJ
implant performance. This method will be based on a comparison of kinematic
parameters of the arthroplastic- and the healthy contralateral DRUJ.
Study design
This study is a cross sectional study. Both forearms will be subjected to one
3D-CT scan and three 4D-CT scans. The 4D-CT scans will be performed during
forearm rotation (pronation to supination) and wrist movement (extension to
flexion). Further performance characteristics will be analysed by performing a
grip strength measurement, a goniometric measurement and by filling out a short
questionnaire. We will include patients from the Academic Medical Center,
Amsterdam. Processing of the 4D data will also be conducted at the Academic
Medical Center, Amsterdam.
Study burden and risks
The radiation exposure the patient will receive falls within category IIa of
the International Commission on Radiological Protection (ICRP), which qualifies
as: minor.
While radiation exposure does not allow unlimitedly forearm imaging, due to the
absence of organs in limbs, radiation risks are extremely low. As motion is
guided
voluntary, there is no risk of harm either. Findings from 4D-CT scans will be
used
for a better decision making for future patients with regard to implant
placement and sizing as well as improving the design of new DRUJ implants.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients have undergone unilateral arthroplasty of the DRUJ by use of an
Aptis Scheker prosthesis, at least six months after the procedure.
- Patients have undergone the procedure at the Academic medical centre,
Amsterdam
- Patients are over the age of 18 years
- Patients are willing to give informed consent
Exclusion criteria
- A history of trauma or injury to the contralateral forearm
- Not able to understand or give informed consent
- Pregnancy
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 | NL76173.018.21 |