The clinical result of the CFP prosthesis is equal to or better than the clinical results of the SPII prosthesis in patients with osteoarthritis above the age of 70.Secondary purpose:Is there a difference between the scores of the SPII and CFP total…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The clinical result of the CFP is equal or better than the clinical result of
the SPII prosthesis in patients with coxarthrosis of 70 years or older.
Primary outcome will be clinical effectiveness, measured with the HOOS
classification. Definition of success of the individual patient is: clinical
non-relevant difference as 9-point difference or less on the HOOS pain scale.
Secondary outcome
a. secondary outcome measures (base line values, VAS, SF-36, HHS during the
total follow up period and in numbers of peri- and postoperative complications,
revision rate, bone density, blood loss and incidence of the Trendelenburg
sign) of the CFP prostheses are equivalent or better than of the SPII
prostheses.
b. The operation procedure of the CFP prosthesis is significant shorter than
that of the SPII prosthesis (non-inferiority).
c. The x-ray and bone density parameters are different in the CFP patient
population in de midterm follow up compared to the SPII group.
Background summary
In total hip arthroplasty, surgeons have the choice out of several types of hip
prostheses. One of these is the SPII cemented total hip arthroplasty. The
Swedish national joint register is leading worldwide in reporting the
nationwide survival rates of hip protheses. This register reports the SPII as
one of the prostheses with the best survival rate. The SPII is a cemented hip
arthroplasty that is implanted in older patients (biologically older than 65
years old). Apart from this cemented prosthesis is the so called uncemented hip
prosthesis implanted without the use of cement. For this kind of prothesis a
sufficient bone quality is necessary to obtain an initial adequate press fit
fixation and secondary bone ingrowth. Within this group of implants a third
generation prosthesis is developed, the bone preserving CFP (Collum Femoris
Preserving). This implant foresees in preserving precious femoral neck bone, so
that in the event of a revision operation sufficient bone will be present for
the fixation of a new femoral prosthesis. The CFP femoral prosthesis is
nowadays used for young, active patients with good bone quality.
Study objective
The clinical result of the CFP prosthesis is equal to or better than the
clinical results of the SPII prosthesis in patients with osteoarthritis above
the age of 70.
Secondary purpose:
Is there a difference between the scores of the SPII and CFP total hip
prosthesis concerning base line values, VAS, SF-36, HHS during the total follow
up period and in numbers of peri- and postoperative complications, revision
rate, bone density, blood loss and incidence of the Trendelenburg sign.
Is the operation procedure implanting the CFP prosthesis significantly shorter
than implanting the SPII prosthesis? What is the 5-year survival rate (revision
any reason) of the tested CFP and SPII implants.
Study design
Single centre randomised controlled clinical trial, comparing two types of hip
prostheses. Patients and principal investigator (acessor) are blinded for the
period of 1 year. Patient follow up will be 5 years in total, with several time
points of clinical and radiological assessment.
Intervention
Implanting a total hip prosthesis; the femoral part being a noncemented CFP
prosthesis or a cemented SPII prosthesis.
Study burden and risks
There are two catagories of risk factors for the patients in this study:
a. general surgical risks
b. orthopaedic total hip implantation risks
These risks are no different from the patients receiving a total hip prosthesis
outside this study.
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
1. Patients who signed the informed consent
2. Patients older than 70 years at the time of the operation
3. Patients who have symptomatic osteoarthritis of the hip and eligible for a
total hip arthroplasty
4. Patients need to be physically and mentally capable to attend the follow up
visits or have a partner of caretaker to make sure these visits can be met.
Exclusion criteria
1. Standard contraindications, as prevailing for elective cemented total hip
arthroplasty (infection, severe comorbidity of pulmonary, cardiac or metabolic
nature)
2. History of arthrodesis
3. Neurological disorders influencing walking ability.
4.Femur Dorr type 3 (calculated by the Flare index)
5. Cognitive disorder
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 | NL25444.075.08 |