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Fitmore Versus CLS Stem in Total Hip Arthroplasty. Bilateral One-stage Operations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03112785
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Johan Karrholm, Sahlgrenska University Hospital, Sweden

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cimetidine


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Zimmer Biomet
Investigators
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Principal Investigator: Johan N Kärrholm, MD, Professor Sahlgrenska University Hospital, Sweden
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Responsible Party: Johan Karrholm, MD Professor in Orhopaedics, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03112785    
Other Study ID Numbers: Fitmore2011
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johan Karrholm, Sahlgrenska University Hospital, Sweden:
Hip
Arthroplasty
Stem
Outcome
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors