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RSA Study of Furlong Evolution With and Without Collar

Primary Purpose

Hip Replacement in Osteoarthritis Patients

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Stem collar
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Replacement in Osteoarthritis Patients focused on measuring Radiostereometry, Total Hip Arthroplasty, Stem design

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary osteoarthritis of the hip necessitating primary hip replacement
  • A femur considered suitable for uncemented fixation of the stem
  • Biological age <75 years old at the inclusion time of the study.

Exclusion Criteria:

  • Rheumatoid arthritis
  • Malignant disease
  • Severe osteoporosis
  • Earlier fracture or operation in the hip to be operated on
  • Peroperative fracture
  • Ongoing corticosteroid (oral) or immunosuppressive medication
  • Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.

Sites / Locations

  • Department of Orthopedics, Skane University Hospital, Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Stem collar

No Stem collar

Arm Description

The stem has two versions, one with and one without a collar. This arm will have stems with a collar. The classical Furlong HAC had a collar.

The stem has two versions, one with and one without a collar. This arm will have stems without a collar. The classical Furlong HAC had a collar.

Outcomes

Primary Outcome Measures

Radiostereometric Analysis (RSA)
This will measure the change in migration (translation and rotation around the x-, y-, and z-axis of the hip) over time. The migration pattern the first 2 years can predict the long term outcome.

Secondary Outcome Measures

Dual-energy X-ray absorptiometry (DXA)
This will measure the change in bone density around the prosthesis during the first important year. This will tell if there is a bone resorption around the stem or cup.
General health questionnaire
EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome over time
Hip specific health questionnaire
Hip disability and Osteoarthritis Outcome Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients function and pain situation.

Full Information

First Posted
July 1, 2013
Last Updated
November 21, 2022
Sponsor
Region Skane
Collaborators
JRI Orthopaedics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01894854
Brief Title
RSA Study of Furlong Evolution With and Without Collar
Official Title
Evaluation of the Furlong Evolution Uncemented Hip Prosthesis With Special Emphasize on the Use of Collared Design or Not. A Prospective, Randomized Study Evaluated by RadioStereometric Analysis (RSA) and DXA.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
JRI Orthopaedics Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to further investigate the clinical and radiological importance of design changes in cementless hip prosthesis. The investigators have earlier evaluated the classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore, comes with and without a collar, and the investigators are going to randomize between the two. The investigators hypothesize that the new design will be easier to implant and will present equal or less migration than the older designs which would imply a favourable outcome in the long term. The investigators further hypothesize that the collar play no major part for the long term migration and bone remodelling. We will now do a 10 year follow up of the patients including RSA, DXA and PROMS

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Replacement in Osteoarthritis Patients
Keywords
Radiostereometry, Total Hip Arthroplasty, Stem design

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem collar
Arm Type
No Intervention
Arm Description
The stem has two versions, one with and one without a collar. This arm will have stems with a collar. The classical Furlong HAC had a collar.
Arm Title
No Stem collar
Arm Type
Active Comparator
Arm Description
The stem has two versions, one with and one without a collar. This arm will have stems without a collar. The classical Furlong HAC had a collar.
Intervention Type
Procedure
Intervention Name(s)
Stem collar
Other Intervention Name(s)
Furlong Evolution with collar, Furlong Evolution without collar
Intervention Description
The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar.
Primary Outcome Measure Information:
Title
Radiostereometric Analysis (RSA)
Description
This will measure the change in migration (translation and rotation around the x-, y-, and z-axis of the hip) over time. The migration pattern the first 2 years can predict the long term outcome.
Time Frame
The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years
Secondary Outcome Measure Information:
Title
Dual-energy X-ray absorptiometry (DXA)
Description
This will measure the change in bone density around the prosthesis during the first important year. This will tell if there is a bone resorption around the stem or cup.
Time Frame
14 days postoperatively and after 1, 5 and 10 years
Title
General health questionnaire
Description
EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome over time
Time Frame
Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively
Title
Hip specific health questionnaire
Description
Hip disability and Osteoarthritis Outcome Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients function and pain situation.
Time Frame
Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary osteoarthritis of the hip necessitating primary hip replacement A femur considered suitable for uncemented fixation of the stem Biological age <75 years old at the inclusion time of the study. Exclusion Criteria: Rheumatoid arthritis Malignant disease Severe osteoporosis Earlier fracture or operation in the hip to be operated on Peroperative fracture Ongoing corticosteroid (oral) or immunosuppressive medication Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Flivik, MD PhD
Organizational Affiliation
Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedics, Skane University Hospital, Lund University
City
Lund
State/Province
Skåne
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34841462
Citation
Belfrage O, Weber E, Sundberg M, Flivik G. Preserved periprosthetic bone stock at 5 years post-operatively with uncemented short hip stem in both collared and collarless version. Arch Orthop Trauma Surg. 2022 Nov;142(11):3489-3496. doi: 10.1007/s00402-021-04225-z. Epub 2021 Nov 29.
Results Reference
derived

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RSA Study of Furlong Evolution With and Without Collar

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