OsteoarthritisPhase 3NCT00208468
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 Phase 3 study testing European Hip, Zweymüller and CLS Spotorno in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 3 sites in 3 countries.
Trial summary
This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- What is being tested?
- European Hip, Zweymüller and CLS Spotorno
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2000to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age - The subject's age is between 18 and 75 years inclusive.
- Sex - Male or female subjects may be recruited to the study.
- 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.
- Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study.
Who cannot join
- Subjects undergoing revision procedure to the operative hip.
- Subjects who have had a previous femoral osteotomy to the operative hip.
- Subjects who have a history of active sepsis in the joint.
- Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).
- 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.
- Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation.
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- Subject's whose weight is > 100kg.
- Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only).
- Subjects who have a fracture of the femur > 6 months old (RSA and DEXA subjects only).
- Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only)
- Subjects with a known history of poor compliance to medical treatment.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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
This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures
- Being tested
- European Hip, Zweymüller, CLS Spotorno
- Keywords
- Hip, Cementless
- Medical subject headings
- Osteoarthritis, Collagen Diseases, Osteonecrosis, Hip Dislocation, Congenital, Slipped Capital Femoral Epiphyses, Legg-Calve-Perthes Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European HipDevice
A cementless femoral component for use in total hip replacement
ZweymüllerDevice
A cementless femoral component for use in total hip replacement
CLS SpotornoDevice
A cementless femoral component for use in total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| European Hip | Other | A cementless femoral component for use in total hip replacement Receives: Device: European Hip |
| Zweymüller | Active comparator | A cementless femoral component for use in total hip replacement Receives: Device: Zweymüller |
| CLS Spotorno | Active comparator | A cementless femoral component for use in total hip replacement Receives: Device: CLS Spotorno |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.
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.
Measured: 2yrs post-surgery
Secondary outcomes (61)
Implant survivorship at 5 and 10 years.
This post market study was terminated early; therefore the 5 and 10 year data was not collected.
Measured: 5 & 10 year post-op
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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.
Measured: 3 Months post-op
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
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.
Measured: 6 Months post-op
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
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.
Measured: 12 months post-op
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
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.
Measured: 24 months post-op
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 and 10 year data was not collected
Measured: 5 & 10 years post-op
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
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.
Measured: 3 months post-op
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
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.
Measured: 6 months post-op
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
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.
Measured: 12 months post-op
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
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.
Measured: 24 months post-op
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Measured: 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
This post-market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 year post-op
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 3 months post-op
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 6 months post-op
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 12 months post-op
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 24 months post-op
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 years post-op
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 3 months post-op
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 6 months post-op
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 12 months post-op
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Measured: 24 months post-op
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 years post-op
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 3 months post-op
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Measured: 6 months post-op
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 12 months post-op
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 24 months post-op
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 years post-op
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 3 months post-op
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Measured: 6 months post-op
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Measured: 12 months post-op
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Measured: 24 months post-op
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 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
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'.
Measured: 3 months post-op
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
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'
Measured: 6 months post-op
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
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'.
Measured: 12 months post-op
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
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'.
Measured: 24 months post-op
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 years post-op
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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).
Measured: 3 months post-op
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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).
Measured: 6 months post-op
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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).
Measured: 12 months post-op
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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).
Measured: 24 months post-op
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 years post-op
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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.
Measured: 3 months post-op
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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.
Measured: 6 months post-op
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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.
Measured: 12 months post-op
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
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.
Measured: 24 months post-op
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 years post-op
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
Measured: 3 months post-op
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
Measured: 6 months post-op
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket
Measured: 12 months post-op
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
Measured: 24 months post-op
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Measured: 5 & 10 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2000
- Primary completionJun 2005
- Study completionMar 2015
Why it stopped: Slow recruitment, investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208468
- Sponsor's protocol ID
- CT99/02
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2005
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00208468
- Acronym / sponsor ID
- CT99/02
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures
- Keywords
- Hip, Cementless
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio.
- Enrolment
- 317 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Jun 2005 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| European Hip | Other | Device: European HipA cementless femoral component for use in total hip replacement |
| Zweymüller | Active comparator | Device: ZweymüllerA cementless femoral component for use in total hip replacement |
| CLS Spotorno | Active comparator | Device: CLS SpotornoA cementless femoral component for use in total hip replacement |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Age - The subject's age is between 18 and 75 years inclusive.
- Sex - Male or female subjects may be recruited to the study.
- 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.
- Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study.
Key exclusion criteria (11 listed)
- Subjects undergoing revision procedure to the operative hip.
- Subjects who have had a previous femoral osteotomy to the operative hip.
- Subjects who have a history of active sepsis in the joint.
- Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| European HipA cementless femoral component for use in total hip replacement | Device | European Hip |
| ZweymüllerA cementless femoral component for use in total hip replacement | Device | Zweymüller |
| CLS SpotornoA cementless femoral component for use in total hip replacement | Device | CLS Spotorno |
Primary outcome
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.
61 secondary outcomes
Implant survivorship at 5 and 10 years.
Time frame: 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
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
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
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
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
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
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
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
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
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
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
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
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
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Time frame: 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
Results and safety
The study was stopped early (reason given: Slow recruitment, investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing European Hip, Zweymüller and CLS Spotorno in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment, investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.