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
About this trial
This is an interventional treatment trial for Primary Osteoarthritis of Hip Nos focused on measuring short stem
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
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
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
Learn more about this trial
Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length
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