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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
317
A cementless femoral component for use in total hip replacement
A cementless femoral component for use in total hip replacement
A cementless femoral component for use in total hip replacement
Univ. Kliniken
Graz, Austria
Univesitätsklinikum Jena
Eisenberg, Germany
InstitutoAzienda Gaetano Pini
Milan, Italy
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.
Time frame: 2yrs post-surgery
Implant survivorship at 5 and 10 years.
This post market study was terminated early; therefore the 5 and 10 year data was not collected.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
This post market study was terminated early; therefore the 5 \& 10 year data was not collected
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
Width of lucency increases over time or expands lengthwise (into neighboring zones).
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
This post-market study was terminated early; therefore the 5 \& 10 year data was not collected
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
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
Component moves away, continuously over time, from its immediate post-operative position.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
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
Component moves away, continuously over time, from its immediate post-operative position.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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'.
Time frame: 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'
Time frame: 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'.
Time frame: 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'.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 5 & 10 years post-op
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