Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty
Primary Purpose
Osteoarthritis, Hip
Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
articular surface replacement ASR, DePuy
ReCap/Magnum modular head, Biomet
Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Arthroplasty, Replacement, Hip, Bone Density, Rehabilitation, T-Lymphocytes, Chromium Alloys
Eligibility Criteria
Inclusion Criteria:
- Primary hip osteoarthritis
- Secondary osteoarthritis due to mild dysplasia
- Age from 40 to 65 years
Exclusion Criteria:
- Dysplasia with CE angle < 25 degrees on the AP projection
- Severe femoral head deformation
- Reduced femoral neck length
- Leg length discrepancy more than 1 cm
- Need for restoration of offset
- Deformation after fractures or earlier osteotomies
- A previous hip arthroplasty
- Inflammatory arthritis
- Endocrinological disease with bone metabolic manifestations
- Renal disease
- Malignant disease
- Neuro/muscular or vascular diseases of the affected leg
- Osteoporosis
- Use of opioid pain killers due to other diseases
- High dose corticosteroids
- Obese with BMI > 35
- Pregnant or planning to be
- Ppresented problems that would prevent completing our follow-up program
Sites / Locations
- Naestved Hospital Dept. of orthop. surg.
- Odense University hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
resurfacing
large head THA
28 mm ceramics-polyethylene
28 mm metal-polyethylene THA
Arm Description
a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint
a standard stemmed THA but with a large metal head, and a metal-metal articulation
a standard 28 mm head uncemented THA
a standard stemmed uncemented THA
Outcomes
Primary Outcome Measures
Range of motion
range of motion in the hip joint evaluated by goniometer
Range of motion
Range of motion of the hip joint
Range of motion
range of motion in the hip joint
Range of motion
range of motion in the hip joint
range of motion
range of motion in the hip joint
Secondary Outcome Measures
Metal ions
Crome and cobalt ions in serum and whole blood.
BMD
bone mass density around the implants
RSA
radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone
HHS
Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion
UCLA activity
University of California Los Angeles activity score. A score over the intensity of activities the patient engages in.
WOMAC
patient reported outcome of pain, stifness and disability during activities of daily living.
EQ-5d
a short quality of life measure. patient reported
T cell count
quantitative analysis of the level of T-cells in the blood
X-ray
an assesment of the placement of the metal cup. Inclination and anteversion.
steps
using a pedometer 1 week prior to each check up the annual step rate is calculated
sick leave
an assesment of the rehabilitation period following the intervention
Metal ions
Crom and cobalt
Metal ions
Crome and cobalt
Metal ions
crome and cobalt
metal ions
crome and cobalt
BMD
bone mass desity around the implant
BMD
Bone mass density around the implant
BMD
Bone mass density around the implant
RSA
Radiostereometry of implant
RSA
Radiostereometry of implant
RSA
Radiostereometry of implant
RSA
Radiostereometry of implant
HHS
Harris hip score
HHS
Harris hip score
HHS
Harris hip score
HHS
Harris hip score
UCLA activity
activity score
UCLA activity
activity score
UCLA activity
activity score
UCLA activity
activity score
WOMAC
self reported function
WOMAC
self reported function
WOMAC
self reported function
WOMAC
self reported function
WOMAC
self reported function
WOMAC
self reported function
EQ-5d
quality of life
EQ-5d
quality of life
EQ-5d
quality of life
EQ-5d
quality of life
T cell count
T cell count
T cell count
T cell count
T cell count
T cell count
T cell count
T cell count
steps
steps measured by pedometer during the week prior to check up
steps
steps measured by pedometer during the week prior to check up
steps
steps measured by pedometer during the week prior to check up
steps
steps measured by pedometer during the week prior to check up
blood loss
blood loss measured in mL
days in hospital
days in hospital following surgery
complications
surgery and implant related complications
surgery time
time from skin is incised to skin is closed
incision length
the length of the surgical incision in cm
Full Information
NCT ID
NCT01113762
First Posted
April 28, 2010
Last Updated
December 17, 2017
Sponsor
University of Southern Denmark
Collaborators
Ministry of the Interior and Health, Denmark, Region Zealand, Zimmer Biomet, DePuy Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT01113762
Brief Title
Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty
Official Title
Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Ministry of the Interior and Health, Denmark, Region Zealand, Zimmer Biomet, DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant.
The investigators hypothesis is:
That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.
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, Bone Density, Rehabilitation, T-Lymphocytes, Chromium Alloys
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
resurfacing
Arm Type
Experimental
Arm Description
a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint
Arm Title
large head THA
Arm Type
Experimental
Arm Description
a standard stemmed THA but with a large metal head, and a metal-metal articulation
Arm Title
28 mm ceramics-polyethylene
Arm Type
Active Comparator
Arm Description
a standard 28 mm head uncemented THA
Arm Title
28 mm metal-polyethylene THA
Arm Type
Active Comparator
Arm Description
a standard stemmed uncemented THA
Intervention Type
Device
Intervention Name(s)
articular surface replacement ASR, DePuy
Intervention Description
posterolateral incision
Intervention Type
Device
Intervention Name(s)
ReCap/Magnum modular head, Biomet
Intervention Description
posterolateral incision
Intervention Type
Device
Intervention Name(s)
Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
Intervention Description
posterolateral incision
Intervention Type
Device
Intervention Name(s)
28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)
Intervention Description
posterolateral incision
Primary Outcome Measure Information:
Title
Range of motion
Description
range of motion in the hip joint evaluated by goniometer
Time Frame
Up to two months before surgery
Title
Range of motion
Description
Range of motion of the hip joint
Time Frame
8 weeks +/- 1 week
Title
Range of motion
Description
range of motion in the hip joint
Time Frame
6 months +/- 2 weeks
Title
Range of motion
Description
range of motion in the hip joint
Time Frame
1 year +/- 1 month
Title
range of motion
Description
range of motion in the hip joint
Time Frame
2 year +/- 1 month
Secondary Outcome Measure Information:
Title
Metal ions
Description
Crome and cobalt ions in serum and whole blood.
Time Frame
Up to two months before surgery
Title
BMD
Description
bone mass density around the implants
Time Frame
Within the first week following surgery
Title
RSA
Description
radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone
Time Frame
Within the first week following surgery
Title
HHS
Description
Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion
Time Frame
Up to two months before surgery
Title
UCLA activity
Description
University of California Los Angeles activity score. A score over the intensity of activities the patient engages in.
Time Frame
Up to two months before surgery
Title
WOMAC
Description
patient reported outcome of pain, stifness and disability during activities of daily living.
Time Frame
Up to two months before surgery
Title
EQ-5d
Description
a short quality of life measure. patient reported
Time Frame
Up to two months before surgery
Title
T cell count
Description
quantitative analysis of the level of T-cells in the blood
Time Frame
Up to two months before surgery
Title
X-ray
Description
an assesment of the placement of the metal cup. Inclination and anteversion.
Time Frame
within 2 years of surgery
Title
steps
Description
using a pedometer 1 week prior to each check up the annual step rate is calculated
Time Frame
Up to two months before surgery
Title
sick leave
Description
an assesment of the rehabilitation period following the intervention
Time Frame
assesed 6 months following surgery.
Title
Metal ions
Description
Crom and cobalt
Time Frame
8 weeks +/- 1 week
Title
Metal ions
Description
Crome and cobalt
Time Frame
6 months +/- 2 weeks
Title
Metal ions
Description
crome and cobalt
Time Frame
1 year +/- 1 month
Title
metal ions
Description
crome and cobalt
Time Frame
2 year +/- 1 month
Title
BMD
Description
bone mass desity around the implant
Time Frame
8 weeks +/- 1 week
Title
BMD
Description
Bone mass density around the implant
Time Frame
1 year +/- 1 month
Title
BMD
Description
Bone mass density around the implant
Time Frame
2 year +/- 1 month
Title
RSA
Description
Radiostereometry of implant
Time Frame
8 weeks +/- 1 week
Title
RSA
Description
Radiostereometry of implant
Time Frame
6 months +/- 2 weeks
Title
RSA
Description
Radiostereometry of implant
Time Frame
1 year +/- 1 month
Title
RSA
Description
Radiostereometry of implant
Time Frame
2 year +/- 1 month
Title
HHS
Description
Harris hip score
Time Frame
8 weeks +/- 1 week
Title
HHS
Description
Harris hip score
Time Frame
6 months +/- 2 weeks
Title
HHS
Description
Harris hip score
Time Frame
1 year +/- 1 month
Title
HHS
Description
Harris hip score
Time Frame
2 years +/- 1 month
Title
UCLA activity
Description
activity score
Time Frame
8 weeks +/- 1 week
Title
UCLA activity
Description
activity score
Time Frame
6 months +/- 2 weeks
Title
UCLA activity
Description
activity score
Time Frame
1 year +/- 1 month
Title
UCLA activity
Description
activity score
Time Frame
2 years +/- 1 month
Title
WOMAC
Description
self reported function
Time Frame
3 weeks
Title
WOMAC
Description
self reported function
Time Frame
6 weeks
Title
WOMAC
Description
self reported function
Time Frame
8 weeks +/- 1 week
Title
WOMAC
Description
self reported function
Time Frame
6 months +/- 2 weeks
Title
WOMAC
Description
self reported function
Time Frame
1 year +/- 1 month
Title
WOMAC
Description
self reported function
Time Frame
2 years +/- 1 month
Title
EQ-5d
Description
quality of life
Time Frame
8 weeks +/- 1 week
Title
EQ-5d
Description
quality of life
Time Frame
6 months +/- 2 weeks
Title
EQ-5d
Description
quality of life
Time Frame
1 year +/- 1 month
Title
EQ-5d
Description
quality of life
Time Frame
2 years +/- 1 month
Title
T cell count
Description
T cell count
Time Frame
8 weeks +/- 1 week
Title
T cell count
Description
T cell count
Time Frame
6 months +/- 2 weeks
Title
T cell count
Description
T cell count
Time Frame
1 year +/- 1 month
Title
T cell count
Description
T cell count
Time Frame
2 years +/- 1 month
Title
steps
Description
steps measured by pedometer during the week prior to check up
Time Frame
8 weeks +/- 1 week
Title
steps
Description
steps measured by pedometer during the week prior to check up
Time Frame
6 months +/- 2 weeks
Title
steps
Description
steps measured by pedometer during the week prior to check up
Time Frame
1 year +/- 1 month
Title
steps
Description
steps measured by pedometer during the week prior to check up
Time Frame
2 years +/- 1 month
Title
blood loss
Description
blood loss measured in mL
Time Frame
during surgery
Title
days in hospital
Description
days in hospital following surgery
Time Frame
from admission to discharge from hospital
Title
complications
Description
surgery and implant related complications
Time Frame
within the first 2 years following surgery
Title
surgery time
Description
time from skin is incised to skin is closed
Time Frame
during surgery
Title
incision length
Description
the length of the surgical incision in cm
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary hip osteoarthritis
Secondary osteoarthritis due to mild dysplasia
Age from 40 to 65 years
Exclusion Criteria:
Dysplasia with CE angle < 25 degrees on the AP projection
Severe femoral head deformation
Reduced femoral neck length
Leg length discrepancy more than 1 cm
Need for restoration of offset
Deformation after fractures or earlier osteotomies
A previous hip arthroplasty
Inflammatory arthritis
Endocrinological disease with bone metabolic manifestations
Renal disease
Malignant disease
Neuro/muscular or vascular diseases of the affected leg
Osteoporosis
Use of opioid pain killers due to other diseases
High dose corticosteroids
Obese with BMI > 35
Pregnant or planning to be
Ppresented problems that would prevent completing our follow-up program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soeren Overgaard, MD, professor, phd
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naestved Hospital Dept. of orthop. surg.
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Odense University hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23597114
Citation
Penny JO, Varmarken JE, Ovesen O, Nielsen C, Overgaard S. Metal ion levels and lymphocyte counts: ASR hip resurfacing prosthesis vs. standard THA: 2-year results from a randomized study. Acta Orthop. 2013 Apr;84(2):130-7. doi: 10.3109/17453674.2013.784657.
Results Reference
derived
PubMed Identifier
23530872
Citation
Penny JO, Ovesen O, Varmarken JE, Overgaard S. Similar range of motion and function after resurfacing large-head or standard total hip arthroplasty. Acta Orthop. 2013 Jun;84(3):246-53. doi: 10.3109/17453674.2013.788435. Epub 2013 Mar 26.
Results Reference
derived
PubMed Identifier
21975150
Citation
Nissen T, Douw K, Overgaard S. Patient-reported outcome of hip resurfacing arthroplasty and standard total hip replacement after short-term follow-up. Dan Med Bull. 2011 Oct;58(10):A4310.
Results Reference
derived
Learn more about this trial
Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty
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