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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Perthes Disease
Keywords: Hip
Cementless
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 317
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.
timeFrame: 2yrs post-surgery
Secondary outcomes:
measure: Implant survivorship at 5 and 10 years.
timeFrame: 5 & 10 year post-op
measure: To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 3 Months post-op
measure: To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 Months post-op
measure: To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
measure: To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5& 10 years post-op
measure: Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
measure: Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 month post-op
measure: Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 year post-op
measure: Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
measure: Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
measure: Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
measure: Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
measure: Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
measure: To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 3 months post-op
measure: To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 6 months post-op
measure: To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 12 months post-op
measure: To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 24 months post-op
measure: To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 5 & 10 years post-op
measure: To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 3 months post-op
measure: To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 6 months post-op
measure: To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 12 months post-op
measure: To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 24 months post-op
measure: To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
timeFrame: 5 & 10 years post-op
measure: To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 3 months post-op
measure: To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 6 months post-op
measure: To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 12 months post-op
measure: To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 24 months post-op
measure: To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
timeFrame: 5 & 10 years post-op
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Univ. Kliniken
city: Eisenberg
country: Germany
facility: Univesitätsklinikum Jena
city: Milan
country: Italy
facility: InstitutoAzienda Gaetano Pini
Study officials:
References: