Surgical Treatment Clinical Trial
Official title:
Randomized Comparison Between the Fitmore and the CLS Stem in Patients Operated in One-stage Due to Bilateral Symptomatous Hip Disease
Verified date | April 2017 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Main question: Will use of a stem design that allows anatomical reconstruction of the hip
joint improve the outcome in terms of hip function and patient satisfaction without causing
any adverse effects?
Background: Total hip arthroplasty with use of the most well documented implants is a safe
and cost-effective procedure. In the Swedish Hip Arthroplasty register the CLS stem has a 16
years implant survival of 97, 5 %. It is a classic design which requires resection of most
of the neck. The stem also intrudes into the greater trochanter which in patients with
certain types of proximal hip anatomy makes proper introduction of the stem difficult.
Finally it has a standard stem length which will jeopardise future stem removal should there
occur any late infection or instability problems.
Short uncemented stems have been introduced to enable a more anatomic reconstruction of the
hip joint and to cause less invasion of the femoral canal to facilitate future revision
should it be necessary. A more conservative resection of neck could also be of value to
improve the clinical outcome by improved hip function and patient satisfaction.
Purpose of the present study and design: In a prospective study the clinical outcome, stem
fixation and bone remodelling around a short stem (Fitmore) will be studied. The main focus
will be to evaluate patient reported outcomes especially concerning function, over all
satisfaction, pain and activity. All patients will receive the same cup (Trilogy). This cup
is chosen because it has a very thorough documentation in prospective RSA studies and in the
Swedish hip arthroplasty register. All cups will be supplied with insert made of high
molecular polyethylene (Longevity).
Number of hips in the study: 44 consecutive cases
Status | Active, not recruiting |
Enrollment | 44 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Hip anatomy suitable for the Fitmore stem according to preoperative planning 2. Males and females aged 35 to 75 years (with bilateral hip disease). 3. Primary osteoarthritis. 4. Secondary osteoarthritis due to idiopathic femoral head necrosis, childhood or inflammatory disease. - Exclusion Criteria: 1. Treatment with Cortisol or known osteoporosis. 2. Low expected activity rate due to other diseases including any generalized joint disease. 3. Anatomy unsuitable for the Fitmore stem. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden | Zimmer Biomet |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preferred hip (the hip arthroplasty preferred by the patient, right or left side) | Study specific protocol in which the patient from a general view tics one of 3 options: left side, right side or no difference). In the term preferred view the patient is asked to consider all aspects they Think are important such as freedom from pain, mobility, function or any other type of discomfort. | 2 years | |
Secondary | Stem subsidence (distal migration of the stem) | Stem subsidence in mm (distal migration of the femoral head center) measured with radiostereometry | 2 years | |
Secondary | Extent of radiolucent lines around the stem | Development of radiolucent lines in percent of total stem circumference as measured on conventional radiographs | 2 years | |
Secondary | Any new surgical procedure where the stem is removed or Exchanges (revision of the stem) | Stem Exchange or removal due to loosening, dislocation or periprostheic fracture | 2, 5 and 10 years |
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