A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis, Perthes Disease

Intervention / Treatment
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* Device: European Hip
* Device: Zweymüller
* Device: CLS Spotorno


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: European Hip<br>A cementless femoral component for use in total hip replacement | Device: European Hip<br>* A cementless femoral component for use in total hip replacement<br>|
| Active Comparator: Zweymüller<br>A cementless femoral component for use in total hip replacement | Device: Zweymüller<br>* A cementless femoral component for use in total hip replacement<br>|
| Active Comparator: CLS Spotorno<br>A cementless femoral component for use in total hip replacement | Device: CLS Spotorno<br>* A cementless femoral component for use in total hip replacement<br>|

What is the study measuring?
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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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | This post market study was terminated early; therefore the 5 & 10 year data was not collected | 5 & 10 years post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Cementless