The purpose of the study is to compare the functional result of CFP stem THA with conventional uncemented straight stem THA
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Dutch, English and the German version of the Hip disability and
Osteoarthritis Outcome Score (HOOS) will be our primary endpoint
Secondary outcome
Hb drop perioperatively
Trendelenburg test
Timed Up and Go
complications
Pain on a Numeric Rating Scale (NRS)
use of analgesics
(5 point Likert scale) satisfaction
wound aspect
SF-12 (health related quality of life)
EQ-5D
Harris Hip Score
position of the prosthesis
migration
osteolysis
radiolucency
Background summary
The use of conventional straight stems, such as the Zweymuller stem, have shown
a 10 year survival rate of 90-100%. However, the change of biomechanic forces
with resulting stress shielding is thought to be a major cause of proximal
osteolysis and a potential cause of aseptic loosening in conventional
uncemented straight stems. Further more, straight stem total hip arthroplasty
requires cutting a slot in the lateral tochanteric fossa with possible risk to
the insertion of the gluteus musculature on the greater trochanter. Damage to
the insertion of the gluteus musculature is an important cause of postoperative
pain at the greater trochanter and reduced abductor strength resulting in
limping and a positive Trendelenburg gait.
The CFP was specifically designed to
1. achieve rotational stability by triplanar fixation through the lateral
cortical cylinder of the neck and resistance to varus valgus stress
2. preserve proximal bone stock
3. achieve stable fixation by the neck cortex and impacted metaphyseal bone
4. increase cortical contact and oppose torsion forces by longitudinal ribs
5. create physiological load transfer
6. preserve femoral neck arteries
7. increase osseointegrating with a microporous hydroxyapatite coating
8. preserve gluteal insertions on the greater trochanter
A seven year follow-up study of 353 CFP stem showed 99% good integration, with
only 2 cases of radiographically proven aseptic loosening. Clinical follow-up
showed good functional recovery and DEXA analysis of 10 patients showed minimal
periprosthetic bone los. A two year follow-up migration assessment using
radiostereometry in twenty-six hips showed low migration, suggesting a
favourable long-term outcome.
Study objective
The purpose of the study is to compare the functional result of CFP stem THA
with conventional uncemented straight stem THA
Study design
A prospective patient blinded randomized controlled multicentre study.
randomization:
online blockrandomization
stratified for surgeon
blinding:
patient
assessor
analyses
Intervention
1. Collum Femoris Preserving Stem
2. Straight stem total hip arthroplasty (such as the Zweymuller)
both groups:
Trabecular Oriented Pattern (T.O.P.) cup
Study burden and risks
additional load: Patients will be asked to fill in questionnaires at home,
prior to per-operatively and prior to postoperative outpatient follow-up
visits. These questionnaire require approximately 30 minutes to fill in.
There are no additional interventions.
additoneel risk:
none
Both stems are currently applied in daily clinical practice. Based on current
literature there is nop evidence of superiority of inferiority of one stem over
the other.
Oosterpark 9
1091 AC Amsterdam
NL
Oosterpark 9
1091 AC Amsterdam
NL
Listed location countries
Age
Inclusion criteria
• Male or female being 18 years or older
• Patients meet the criteria for osteoarthritis:
-Pain in hip
-Arthritic changes on radiograph: joint space narrowing
femoral / acetabular osteofytes, cysts and signs of sclerosis
• Patients not responding to conservative therapy
• Written informed consent for study participation
Exclusion criteria
• Patients who are mentally impaired and not able to fill out questionnaires
• Patients who have previously received a THA on the contralateral hip.
• Patients who do not know the Dutch, or English or German language
• Patients with a BMI of more than 40
• Patients with skeletal immaturity
• Patients with a life expectancy of less than 3 years
• Patients with altered anatomy resulting in impossibility for the CFP procedure, according to the surgeon e.g.:
-hip dysplasia with high luxation
-post traumatic severe anatomy change
-post correction osteotomy
• Patients with extremity amputation
• Patients with an active malignant disease or current cytostatic treatment
• Patients who are participating in another trial
• Known alcohol or drug abuse
• Any condition that would impede measurement of efficacy to the opinion of the surgeon
• Patients with a previous contralateral hip arthroplasty
• Patients with avascular head necrosis resulting from sickelcel anemia
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 | NL21637.100.08 |