Objective: non-inferiority in fixation of the SL-PLUS MIA compared to the traditional SL-Plus stem and superiority of the SL-PLUS MIA in terms of bone and muscle preservation and thereby increased patient satisfaction and outcome as measured by PROM…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The primary endpoint will be implant migration
after two years. Migration will be measured by RSA.
Secondary outcome
Secondary endpoints will be bone density alteration measured by DEXA scan,
HOOS scores over time, postoperative pain, patient satisfaction, length of
hospital stay.
Background summary
Rationale: The (Zweymüller) SL-Plus stem produced by Plus Orthopedics (Smith &
Nephew) has an excellent long term survival of 95% at 15 years with revision
for aseptic loosening. However the bulky geometry of the stem impedes minimal
invasive surgery. Slight alterations in design has resulted in the SL-PLUS MIA
(Minimal Invasive Arthroplasty) which is more suitable for less invasive
surgery facilitating in less peroperative bone loss and lesser amount of muscle
damage. Primary fixation of the SL-Plus and SL-PLUS MIA is achieved by distal
press fit fixation of the stem during implantation. The proximal hydroxyapatite
coating of the SL-PLUS MIA stem assists bony ingrowth resulting in secondary
stability.
Study objective
Objective: non-inferiority in fixation of the SL-PLUS MIA compared to the
traditional SL-Plus stem and superiority of the SL-PLUS MIA in terms of bone
and muscle preservation and thereby increased patient satisfaction and outcome
as measured by PROM*s.
Study design
Study design: randomised controlled trial
Intervention
Intervention: after informed consent patients are randomised in one of two
groups. One group receives the currently used traditional SL-Plus stem and the
other group receives the SL-PLUS MIA-stem. Each group will contain 30 patients.
A *Hardinge* approach of the hip is used in both groups.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The burden of participation in this trail will
be the specialized RSA X-rays at follow up, clinical follow up with PROM*s and
the DEXA scan until 2 years after the total hip arthroplasty. The amount of
exposure to radiation will be slightly higher but of no clinical consequence.
van Hemertmarke 17 17
Zwolle 8016AW
NL
van Hemertmarke 17 17
Zwolle 8016AW
NL
Listed location countries
Age
Inclusion criteria
• Patients with primary osteoarthritis of the hip with an indication for total hip arthroplasty.
• Age 50 to 80
• ASA 1 and 2
• unilateral coxartrhosis
• Informed consent of patient
• Initial willingness to comply with the post-operative review program
Exclusion criteria
• Ability to comply to the postoperative investigational program
• THA or osteosynthesis on the contra lateral hip (not suitable as reference during DEXA-scan)
• Expectation that the contra lateral hip also needs a THA within a year
• THA because of fracture
• Prior surgery on effected hip
• Revision arthroplasty
• Acute or chronic infections (local or systemic)
• Metabolic diseases of the bone
• Diseases of the muscular, nervous, or vascular systems that seriously will involve the mobility of the patient after a THA
• Femora with structural defects or poor bone quality affecting the stability of the prosthesis
• Any concomitant disease which may endanger the implant*s function
• Patients with rheumatic, renal, hepatic or gastrointestinal disease and patients using medication that interferes with mineral metabolism (i.e. treatment for osteoporosis or long-term steroid therapy).
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 | NL51323.075.14 |