To determine whether the clinical results of ceramic bearings are as good as expected and to sort out which parameters are influencing the implant survival and complication rate. Efficacy can be measured and the treatment of patients with this type…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is the survival of the prosthesis. The
prosthesis survival is otherwise described as the time between the day of the
primary THA procedure and the day revision surgery is performed, measured in
months.
Secondary outcome
-Radiographic signs of osteolysis in three acetabular zones according to De Lee
and Charnley, and in seven femoral zones according to Gruen, signs of
stress-shielding (loss of trabecular density and decreasing cortical index),
prosthetic migration, fractures.
-Analysis of the reason for prosthetic failure
-Heterotopic ossification according to Brookers classification (I-IV)
-Radiographic analysis of implant positioning on AP and axial images
-Clinical performance and functional outcomes using the Harrison Hip Score
(HHS), patient satisfaction in Visual Analogue Scale (VAS), the anamnestic
incidence of mid thigh pain and groin pain, static and dynamic (2008 Luca et
al.), pain severity during the entire period of follow-up (VAS), squeaking.
-Physical impairments of the hip: gait analysis, Trendelenburg*s sign, strength
and stability, range of motion and leg length.
Background summary
Ceramic bearing materials have shown high potential for primary Total Hip
Arthroplasty (THA) in tribological studies and in vitro analyses. While
clinical results with limited follow up are fluctuating, Ceramic-on-Ceramic
(ConC) prostheses are considered to be a promising alternative for the
conventional THA, especially in young and active patients.
Study objective
To determine whether the clinical results of ceramic bearings are as good as
expected and to sort out which parameters are influencing the implant survival
and complication rate. Efficacy can be measured and the treatment of patients
with this type of prosthesis can be optimized.
Primary objective:
-Determination of prosthesis survival of an uncemented ConC primary THA with
revision for any reason as ending point.
Secondary Objectives:
-Radiographic evaluation of an AP and axial X-ray, focused on periprosthetic
bone loss; Comparison of the post-operative X-rays with X-rays at final follow
up.
-Evaluation of functional outcomes and patient satisfactory using:
1. Physical examination of the hip joint
2. Harris Hip Score (HHS) questionnaires
3. Visual Analogue Scale (VAS) for patient satisfaction and pain
-Identification and analysis of adverse events
-Distillation of potential risk factors for revision
-Determine the relation between the original indication for THA and prosthesis
survival
Study design
A consecutive retrospective single centre case series of all patients with a
minimal follow up of two years.
Study burden and risks
The burden consists of a hospital visit that will require under an hour in
time. Patients will be asked to fill in three questionnaires, two X-rays will
be made en physical examination will be performed. In exchange for the time
spent at filling in the questionnaires and the hospital visit, participators
receive an extensive examination of their THA and its clinical performance.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Patients who have received an uncemented 'ceramics-on-ceramics' Total Hip Arthroplasty in the ErasmusMC during the years 2000 up to and including 2010.
Exclusion criteria
none
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 | NL43307.078.13 |