Status:
COMPLETED
Arcos Revision Stem: Evaluation of Clinical Performance
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief Summary
The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bon...
Detailed Description
Primary Endpoint: survivorship and revision rate up to 5 years post-operatively Secondary Endpoints: Stability and Fixation of Arcos Hip by radiographic assessment, Relationship between bone defect le...
Eligibility Criteria
Inclusion
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
- The Arcos™ Modular Femoral Revision System hip components are single-use implants, intended for uncemented use only.
- Only subjects who have received or have already been scheduled to receive hip surgery with the Arcos Revision Stem System will be included in this outcomes study.
- Additional
- No age limit, however, the patient must have reached full skeletal maturity.
- Willing to return for follow up evaluation.
Exclusion
- Absolute contraindications include: active infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, or neuromuscular disease.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01820611
Start Date
February 1 2013
End Date
June 14 2021
Last Update
January 20 2025
Active Locations (5)
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1
Turku University Hospital
Turku, Finland
2
Hospital Universitari Mutua
Barcelona, Spain
3
Uddevalla Hospital
Uddevalla, Sweden
4
Hinchingbrooke Hosptial
Cambridge, United Kingdom