Fitmore Versus CLS Stem in Total Hip Arthroplasty. Bilateral One-stage Operations
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|ClinicalTrials.gov Identifier: NCT03112785|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Primary Hip Osteoarthritis Secondary Hip Osteoarthritis Due to Idiopathic Femoral Head Necrosis, Childhood or Inflammatory Disease Bilateral Hip Disease Surgical Treatment||Device: Total hip arthroplasty (Fitmore or CLS uncemented femoral stem made by Zimmer-Biomet, Warshaw, USA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients with bilateral degenerative hip osteoarthritis are operated with a short stem total hip arthroplasty on one side and a conventional stem on the opposite side. Implant selection is randomised on the most symptomatic side, the second side receives the type of stem not used on the first one.|
|Masking:||None (Open Label)|
|Official Title:||Randomized Comparison Between the Fitmore and the CLS Stem in Patients Operated in One-stage Due to Bilateral Symptomatous Hip Disease|
|Actual Study Start Date :||March 17, 2011|
|Estimated Primary Completion Date :||June 2026|
|Estimated Study Completion Date :||June 2026|
- Device: Total hip arthroplasty (Fitmore or CLS uncemented femoral stem made by Zimmer-Biomet, Warshaw, USA)
The most symptomatic side is randomised to one of the two stem types studied. If the patient has equal amount of symptoms on both sides, the one with most pronounced degenerative Changes on plain radiographs will be randomised. On the second side the type of stem not used on the first one will be inserted. All patients and allhip will receive the same type and design of cup.
- Preferred hip (the hip arthroplasty preferred by the patient, right or left side) [ Time Frame: 2 years ]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.
- Stem subsidence (distal migration of the stem) [ Time Frame: 2 years ]Stem subsidence in mm (distal migration of the femoral head center) measured with radiostereometry
- Extent of radiolucent lines around the stem [ Time Frame: 2 years ]Development of radiolucent lines in percent of total stem circumference as measured on conventional radiographs
- Any new surgical procedure where the stem is removed or Exchanges (revision of the stem) [ Time Frame: 2, 5 and 10 years ]Stem Exchange or removal due to loosening, dislocation or periprostheic fracture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112785
|Principal Investigator:||Johan N Kärrholm, MD, Professor||Sahlgrenska University Hospital, Sweden|