- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208468
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement
A Multi-centre, Randomised, Parallel Group, Controlled Study to Compare the Performance of the Future Hip Against Three Currently Used Implants in Total Hip Replacement
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
i) Administrative - The subject is able to understand the study, is willing to give voluntary, written, informed consent, will co-operate with assessment procedures and is geographically able to comply with the post-operative follow-up regime.
ii) Age - The subject's age is between 18 and 75 years inclusive.
iii) Sex - Male or female subjects may be recruited to the study.
iv) Diagnosis -Subjects must be undergoing primary THR surgery for non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, post-traumatic arthritis, fractured neck of femur and non-union of fractured neck of femur, SUFE or Perthes disease.
v) Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study.
Exclusion Criteria:
i) Subjects undergoing revision procedure to the operative hip.
ii) Subjects who have had a previous femoral osteotomy to the operative hip.
iii) Subjects who have a history of active sepsis in the joint.
iv) Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).
v) Subjects with any condition which may, in the opinion of the Investigator, interfere with the total hip replacement's survival or outcome, e.g. Paget's disease, Charcot's disease.
vi) Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation.
vii) Subject's whose weight is > 100kg.
viii) Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only).
ix) Subjects who have a fracture of the femur > 6 months old (RSA and DEXA subjects only).
x) Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only)
xi) Subjects with a known history of poor compliance to medical treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: European Hip
A cementless femoral component for use in total hip replacement
|
A cementless femoral component for use in total hip replacement
|
ACTIVE_COMPARATOR: Zweymüller
A cementless femoral component for use in total hip replacement
|
A cementless femoral component for use in total hip replacement
|
ACTIVE_COMPARATOR: CLS Spotorno
A cementless femoral component for use in total hip replacement
|
A cementless femoral component for use in total hip replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.
Time Frame: 2yrs post-surgery
|
Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event.
In this study, the event is removal of any component for any reason, also known as revision for any reason.
|
2yrs post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant survivorship at 5 and 10 years.
Time Frame: 5 & 10 year post-op
|
This post market study was terminated early; therefore the 5 and 10 year data was not collected.
|
5 & 10 year post-op
|
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 3 Months post-op
|
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
|
3 Months post-op
|
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 Months post-op
|
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
|
6 Months post-op
|
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
|
12 months post-op
|
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
The Harris Hip Score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
|
24 months post-op
|
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 and 10 year data was not collected
|
5 & 10 years post-op
|
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
|
3 months post-op
|
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
|
6 months post-op
|
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
|
12 months post-op
|
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
he Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
|
24 months post-op
|
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5& 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5& 10 years post-op
|
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
3 months post-op
|
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
6 months post-op
|
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
12 months post-op
|
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
24 months post-op
|
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
3 months post-op
|
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 month post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
6 month post-op
|
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
12 months post-op
|
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Width of lucency increases over time or expands lengthwise (into neighboring zones).
|
24 months post-op
|
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 year post-op
|
This post-market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 year post-op
|
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
3 months post-op
|
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
6 months post-op
|
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
12 months post-op
|
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
24 months post-op
|
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
3 months post-op
|
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
6 months post-op
|
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
12 months post-op
|
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position
|
24 months post-op
|
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
3 months post-op
|
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position
|
6 months post-op
|
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
12 months post-op
|
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
24 months post-op
|
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
3 months post-op
|
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position.
|
6 months post-op
|
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position
|
12 months post-op
|
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Component moves away, continuously over time, from its immediate post-operative position
|
24 months post-op
|
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft.
Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
|
3 months post-op
|
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft.
Typically, after 6 months the lack of correct healing is classified as a 'non-union'
|
6 months post-op
|
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft.
Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
|
12 months post-op
|
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft.
Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
|
24 months post-op
|
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 3 months post-op
|
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
|
3 months post-op
|
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 6 months post-op
|
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
|
6 months post-op
|
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 12 months post-op
|
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
|
12 months post-op
|
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 24 months post-op
|
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
|
24 months post-op
|
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 3 months post-op
|
Presented by Brooker in JBJS 55a: 1629-1632 (1973).
Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
|
3 months post-op
|
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 6 months post-op
|
Presented by Brooker in JBJS 55a: 1629-1632 (1973).
Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
|
6 months post-op
|
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 12 months post-op
|
Presented by Brooker in JBJS 55a: 1629-1632 (1973).
Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
|
12 months post-op
|
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 24 months post-op
|
Presented by Brooker in JBJS 55a: 1629-1632 (1973).
Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
|
24 months post-op
|
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 3 months post-op
|
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
|
3 months post-op
|
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 6 months post-op
|
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
|
6 months post-op
|
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 12 months post-op
|
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket
|
12 months post-op
|
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 24 months post-op
|
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
|
24 months post-op
|
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time Frame: 5 & 10 years post-op
|
This post market study was terminated early; therefore the 5 & 10 year data was not collected
|
5 & 10 years post-op
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Wounds and Injuries
- Leg Injuries
- Congenital Abnormalities
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bone Diseases
- Hip Injuries
- Femur Head Necrosis
- Osteonecrosis
- Musculoskeletal Abnormalities
- Joint Dislocations
- Bone Diseases, Developmental
- Osteochondrodysplasias
- Epiphyses, Slipped
- Femoral Fractures
- Necrosis
- Fractures, Bone
- Rheumatic Diseases
- Collagen Diseases
- Legg-Calve-Perthes Disease
- Hip Dislocation
- Developmental Dysplasia of the Hip
- Hip Dislocation, Congenital
- Slipped Capital Femoral Epiphyses
Other Study ID Numbers
- CT99/02
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