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Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length

Primary Purpose

Primary Osteoarthritis of Hip Nos, Secondary Osteoarthritis of Hip

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total hip replacement (2 different designs)
Sponsored by
Johan Karrholm
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Osteoarthritis of Hip Nos focused on measuring short stem

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • primary osteoarthritis of hip
  • secondary osteoarthritis due to hip dysplasia or Perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease
  • avascular necrosis of femoral head
  • anatomy suitable for both designs according to preoperative planning

Exclusion Criteria:

  • previous treatment with cortisone
  • generalized joint disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Oxford Hip Score
    The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. It is short, reproducible, valid and sensitive to clinically important changes.
    Radiostereometric analysis
    Radiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. The overall concept of RSA is straightforward: determining the precise location of two distinct objects relative to each other in three dimension (such as the relative position of the femoral component and the proximal femur).

    Secondary Outcome Measures

    Patient satisfaction (VAS), Pain (VAS)
    Patient satisfaction and pain are reported on visual analogue scales.
    Harris hip score
    One of the oldest and most commonly used scores to assess function and pain with patients undergoing hip replacement surgery.

    Full Information

    First Posted
    December 2, 2016
    Last Updated
    April 7, 2017
    Sponsor
    Johan Karrholm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02983526
    Brief Title
    Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Johan Karrholm

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden. The patients were randomized to either CFP or Corail stem, both groups received Delta cup from Lima. Randomisation was done using envelopes. Patients could only participate with one hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.
    Detailed Description
    The concept of femoral neck preserving hip replacement is intended for the young and active patients. By preserving proximal bone load, the transmission to the proximal femur is supposed to improve and future revision surgery would be facilitated. The hypothesis is that a more conservative resection of the femoral neck could lead to better clinical outcomes compared to a conventional stem. The clinical outcomes and the fixation of a short femoral stem were therefore compared with a stem of standard length. 83 patients were included in our randomized controlled trial where patients either received a Collum Femoris Preserving (CFP) stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are studied and the early migration is being measured using radiostereometric analysis. All of the patients have gone through 1 year follow-up. The 2 years results will be available at the end of 2017.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Osteoarthritis of Hip Nos, Secondary Osteoarthritis of Hip
    Keywords
    short stem

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Total hip replacement (2 different designs)
    Other Intervention Name(s)
    CFP stem or Corail stem
    Intervention Description
    Patients will randomly receive either CFP or Corail stem
    Primary Outcome Measure Information:
    Title
    Oxford Hip Score
    Description
    The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. It is short, reproducible, valid and sensitive to clinically important changes.
    Time Frame
    Preoperatively to 2 years
    Title
    Radiostereometric analysis
    Description
    Radiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. The overall concept of RSA is straightforward: determining the precise location of two distinct objects relative to each other in three dimension (such as the relative position of the femoral component and the proximal femur).
    Time Frame
    Preoperatively to 2 years
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction (VAS), Pain (VAS)
    Description
    Patient satisfaction and pain are reported on visual analogue scales.
    Time Frame
    Preoperatively to 2 years
    Title
    Harris hip score
    Description
    One of the oldest and most commonly used scores to assess function and pain with patients undergoing hip replacement surgery.
    Time Frame
    Preoperatively to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: primary osteoarthritis of hip secondary osteoarthritis due to hip dysplasia or Perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease avascular necrosis of femoral head anatomy suitable for both designs according to preoperative planning Exclusion Criteria: previous treatment with cortisone generalized joint disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johan Kärrholm, MD, PhD, Professor
    Organizational Affiliation
    Sahlgrenska University Hospital, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length

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