Objective: To perform a comparative assessment between the clinical, bone remodelling, and radiographic outcomes (as measured with RSA) of the conventional Mallory-Head stem compared two shorter versions of Mallory-Head stems in patients undergoing…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Outcome will be clinically measured using the
Harris Hip Score (HHS), HOOS / WOMAC questionnaire, SF-12, (whilst
radiographic outcomes will be evaluated through standard radiographic
parameters which include qualitative femoral and acetabular findings as well as
position of the stem and cup. RSA will be used to measure stem migration.
Secondary outcome
n.a.
Background summary
Rationale: The stem length must be minimised with assurance that bone stock is
adequate for stability. The use of a stem is important to resist varus/valgus
stress, but it should be as short as possible and with a flexibility as close
to that of the femur as possible to decrease the compressive stresses to the
lateral femoral cortex.
Study objective
Objective: To perform a comparative assessment between the clinical, bone
remodelling, and radiographic outcomes (as measured with RSA) of the
conventional Mallory-Head stem compared two shorter versions of Mallory-Head
stems in patients undergoing primary uncemented THA over a period of 5 years.
Bone remodelling and all complications will be documented.
Study design
Study design: A prospective randomised clinical trial in which 60 cases will be
enrolled. The primary components to be implanted are an uncemented Mallory head
uncemented cup in combination with the short stem Mallory-Head®, the middle
length or the conventional Mallory-Head stem®. All patients will receive a 28
mm Cobalt chrome head. Patients will be evaluated preoperatively and
postoperatively at discharge (from operation date to date of discharge), at 3
months, 1 year, 2 years, 3 years and 5 years.
Intervention
Intervention: Placement of an uncemented primary Mallory-Head® cup in
combination with either the Mallory-Head short stems or the conventional
Mallory-Head stem for primary uncemented THA.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Subjects participating in the study have the
same risks and benefits when not participating in the study. The new components
used in the study are based on designs already in use. The Mallory-Head is
clinically successfully used with an unchanged design since 1987. Follow-up
times are standard protocol evaluations of prothesis. Besides standard
radiologic follow-up, RSA x-rays will be made to measure the fixation of the
stem.
Reinier de Graafweg 3-11
Delft 2625AD
NL
Reinier de Graafweg 3-11
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
1. Male and non pregnant female patients between 18-65 years of age.
2. Patients with a quetelet index (QI<=weight in (kilogram)/ squire length (meters)) < 35
3. Patients requiring uncemented primary THR, suitable for the use of the Mallory Head stem
4. The individual has no clinical relevant contra indications for total hip replacement
5. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis
6. The individual is physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule.
7. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery
Exclusion criteria
1. The patient is unwilling to cooperate with the study
2. The patient has disorders clinically relevant for total hip replacement
3. The patient is pregnant or desired to be pregnant after surgery or is using inadequate birth control
4. Patients who had or will need another joint replacement within six months.
5. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome was considered unsatisfactory or not good. (Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip Score >85) can be included in the study).
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL14527.098.06 |