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Evaluation of a Short Femoral Stem in Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Hip

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short stem hip arthroplasty (SHA)
Total hip arthroplasty (THA)
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, Hip Prosthesis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • receiving primary total hip arthroplasty due to osteoarthritis, posttraumatic arthritis, avascular necrosis, or developmental hip dysplasia (Crowe grade 1)

Exclusion Criteria:

  • osteoporosis
  • pregnancy
  • musculoskeletal problems compromising rehabilitation
  • corticosteroid treatment
  • dementia
  • developmental dysplasia (Crowe grade II-IV)
  • osteosynthesis in place
  • revision surgery
  • joint infection
  • malignancy of the femur/pelvis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Furlong Evolution femoral stem

    Furlong H-A.C. femoral stem

    Arm Description

    Short stem hip arthroplasty (SHA) using a Furlong Evolution femoral stem, and a Furlong H-A.C. Cortical Scree Fit (CSF) plus acetabular cup system.

    Total hip arthroplasty (THA) using a Furlong H-A.C. femoral stem, and a Furlong H-A.C. CSF plus acetabular cup system.

    Outcomes

    Primary Outcome Measures

    Change in periprosthetic bone mineral density (BMD)
    Postoperative change in BMD following bone remodelling measured by dual-energy x-ray absorptiometry (DXA)

    Secondary Outcome Measures

    Migration of femoral stem
    Migration of femoral stem measured by radiostereometric analysis (RSA)
    Biomechanical reconstruction of hip anatomy
    Biomechanical key measures in hip anatomy after reconstruction of the hip joint, compared to native anatomy in contralateral hip is analysed on a metric scale to compare the following positions: Horizontal centre of rotation. Vertical centre of rotation. Horizontal femoral offset. Vertical femoral offset. Abductor lever arm. Limb length. Stem-shaft angle, or valgus/varus.
    Hip disability osteoarthritis outcome score (HOOS)
    Harris hip score
    Health-related quality of life (EQ-5D).

    Full Information

    First Posted
    March 31, 2016
    Last Updated
    December 9, 2019
    Sponsor
    St. Olavs Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02743208
    Brief Title
    Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
    Official Title
    Evaluation of a Short Femoral Stem in Total Hip Arthroplasty. A Comparative Study on Stability, Bone Remodelling and Patient Outcome.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    problem due to new regulations for CE-marking of implants; lack of funding
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    St. Olavs Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In recent years, short femoral stems have been introduced. Short stems are designed based on traditional stems with good clinical results. The assumed benefit of short stems is that they are easier to use in mini-invasive surgery, and that preservation of proximal periprosthetic bone stock is better. Preservation of periprosthetic bone in the proximal femur is thought to secure long time anchoring of the implant, and reduce the risk of loosening. In addition, a good proximal bone stock makes later revision surgery less technically demanding. However, the short stem design could compromise the stability of the prosthesis, and there has been reported diverging results regarding correct positioning of short stems. This may be due to the lack of inherent aiming provided by the tip of the traditional long stems. We want to clinically evaluate the stability and bone remodelling pattern of a new short femoral stem based on a standard stem with excellent long time results. In addition we will compare the two different stems regarding positioning, when using a newly developed guiding broach for the short stem, and the standard broach for the long stem. Finally, patient reported clinical outcome scores will be evaluated with respect to implant and biomechanical reconstruction. The aim of this study is to evaluate whether this specific short femoral stem is stable, safe to use, and if it provides the expected beneficial effects on bone remodelling.
    Detailed Description
    Total hip arthroplasty (THA) is a successful treatment of osteoarthritis and other destructive diseases of the hip joint, relieving pain and restoring the function of the joint. In Norway more than 7000 patients undergo primary hip replacement every year, and the incidence is increasing. The femoral component of a hip prosthesis is traditionally anchored to the femoral bone with a stem introduced into the femoral canal and fixated with cement, or through bony ingrowth. Over the recent years, short femoral stems have been introduced, among other reasons to meet the increasing popularity of mini-invasive surgical procedures. The short stems are meant to be easier to introduce through a small incision like used in muscle conserving anterior and posterior approaches. Secondly, and biomechanically relevant, an important design related benefit of the short femoral stems is thought to prevent periprosthetic bone resorption. Bone remodels as a response to mechanical loading. When a stiff implant is inserted into the femoral canal, the load will "bypass" the proximal femur through the implant, and is transferred to bone distally. This results in a negative bone remodelling in the proximal femur, which leads to bone resorption, often termed as "stress shielding". Stress shielding is observed around most uncemented implants, and mainly occurs within the first 6 - 24 months postoperatively. The extent of implant coating, the material stiffness, design and the size of the stem are found to influence the degree of stress shielding. The short stems are thus designed based on the theory that proximal load transfer preserves metaphyseal bone. Loss of proximal bone stock due to stress shielding is a controversial subject, but has several possible consequences. The exact clinical implications are not entirely determined, but periprosthetic fractures and more challenging revision surgery are recognized problems. In a revision setting it is favourable to have good proximal bone stock to achieve primary stability of the implant. Peroperative fracture and compromised stability of the implant may be a potential problem in stress-shielded bone. Furthermore, already stress-shielded bone in the proximal femur may give wear debris easier access to the interface between implant and bone, resulting in further osteolysis. Short-term results for short-stemmed implants are encouraging in some clinical papers, but most of the available implants lack long-time clinical documentation. Most papers on stress shielding are not randomized trials between long and short stems. There are a few reports of increased revision rate and challenging surgical procedures. Uncemented prosthetic hip implants are dependent on excellent primary stability to achieve osseointegration and long-term stability. It is recognized that excessive micromotion at the bone-implant interface is associated with formation of a soft tissue and loosening of implants. Micromotion above 40μm leads to partial bone ingrowth, while values above 150μm completely inhibit bone ingrowth. The main concern in short femoral stems is that stability might be compromised. This might be due to the relatively less contact surface. There are no long term results on stability of short femoral stems available, but in vitro studies shows no significant reduction in stability of prostheses with comparable stem length to the Furlong Evolution. Malpositioning may result in a discrepancy between the reconstructed and the native biomechanical anatomy of the hip. Altered biomechanical properties may influence the clinical outcome and survival of implants. It has been shown that horizontal femoral offset, increases significantly more using a short femoral stem compared to conventional femoral stems. Compared to the contralateral hip, horizontal femoral offset was significantly increased only when using short stems. Increased femoral offset increases the torsion forces along the stem, which in turn raises the need for primary stability to avoid micromotion. It is also shown that a short stem has a wider range of varus-valgus in the stem-shaft axis, On the other there were found no significant differences in biomechanical reconstruction of the hip when using a "broach only" short stem, or a "ream and broach" standard stem. If there are significant differences in the biomechanical hip reconstruction, will this affect patient reported outcome?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Hip
    Keywords
    Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, Hip Prosthesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Furlong Evolution femoral stem
    Arm Type
    Experimental
    Arm Description
    Short stem hip arthroplasty (SHA) using a Furlong Evolution femoral stem, and a Furlong H-A.C. Cortical Scree Fit (CSF) plus acetabular cup system.
    Arm Title
    Furlong H-A.C. femoral stem
    Arm Type
    Active Comparator
    Arm Description
    Total hip arthroplasty (THA) using a Furlong H-A.C. femoral stem, and a Furlong H-A.C. CSF plus acetabular cup system.
    Intervention Type
    Device
    Intervention Name(s)
    Short stem hip arthroplasty (SHA)
    Intervention Description
    Furlong Evolution femoral stem
    Intervention Type
    Device
    Intervention Name(s)
    Total hip arthroplasty (THA)
    Intervention Description
    Furlong H-A.C. femoral stem
    Primary Outcome Measure Information:
    Title
    Change in periprosthetic bone mineral density (BMD)
    Description
    Postoperative change in BMD following bone remodelling measured by dual-energy x-ray absorptiometry (DXA)
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Migration of femoral stem
    Description
    Migration of femoral stem measured by radiostereometric analysis (RSA)
    Time Frame
    2 years
    Title
    Biomechanical reconstruction of hip anatomy
    Description
    Biomechanical key measures in hip anatomy after reconstruction of the hip joint, compared to native anatomy in contralateral hip is analysed on a metric scale to compare the following positions: Horizontal centre of rotation. Vertical centre of rotation. Horizontal femoral offset. Vertical femoral offset. Abductor lever arm. Limb length. Stem-shaft angle, or valgus/varus.
    Time Frame
    2 years
    Title
    Hip disability osteoarthritis outcome score (HOOS)
    Time Frame
    2 years
    Title
    Harris hip score
    Time Frame
    2 years
    Title
    Health-related quality of life (EQ-5D).
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: receiving primary total hip arthroplasty due to osteoarthritis, posttraumatic arthritis, avascular necrosis, or developmental hip dysplasia (Crowe grade 1) Exclusion Criteria: osteoporosis pregnancy musculoskeletal problems compromising rehabilitation corticosteroid treatment dementia developmental dysplasia (Crowe grade II-IV) osteosynthesis in place revision surgery joint infection malignancy of the femur/pelvis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olav Foss, md phd
    Organizational Affiliation
    St. Olavs Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of a Short Femoral Stem in Total Hip Arthroplasty

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