Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
225 participants
OBSERVATIONAL
2009-03-31
2020-11-30
Brief Summary
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Detailed Description
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Efficacy evaluations:
* Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) \[7, 8\], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
* Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration
Safety evaluations:
* Intra- and perioperative device-related adverse events (AE) and complications up to discharge
* Postoperative AE up to 10 years
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Osteoarthritis
Total Hip Arthroplasty
Eligibility Criteria
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Inclusion Criteria
* Informed consent to participate in the MCO signed by the patient
* Routine radiographic assessment is possible
* Patient is likely to comply with study follow-up requirements
* Primary total hip replacement (THR) to the affected side, unilateral or bilateral
Exclusion Criteria
* History of infection in the affected joint; systemic infections
* Grossly insufficient femoral or acetabular bone stock in the involved hip
* Charcot joint disease or other severe neurosensory deficit
* Severe spinal disorders
* Age of patient at date of surgery \> 75 years
* High comorbidity
* Cemented acetabular cup
18 Years
75 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Turgay Efe, Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Philipps University Marburg
Locations
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St. Elisabeth Hospital, Orthopedics and Rheumatology
Bochum, , Germany
University Marburg, Orthopedics and Rheumatology
Marburg, , Germany
Kantonsspital Aarau, Orthopedics
Aarau, , Switzerland
Countries
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References
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Cypres A, Fiquet A, Girardin P, Fitch D, Bauchu P, Bonnard O, Noyer D, Roy C. Long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis. J Orthop Surg Res. 2019 Nov 21;14(1):376. doi: 10.1186/s13018-019-1436-y.
Other Identifiers
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D10070
Identifier Type: -
Identifier Source: org_study_id