Status:
COMPLETED
RSA Study of Sirius Stem and Exceed Cup
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom polyethylene, and ...
Detailed Description
This is a comparative, prospective randomized Radiostereometry (RSA) study, lead on 48 patients in a single site. All 48 patients will be pooled in a single group for the evaluation of the primary cr...
Eligibility Criteria
Inclusion
- Patients who are eligible for cemented total hip arthroplasty
- Patients diagnosed with primary Osteoarthritis
- Patients who are fit for elective surgery (ASA I - III)
- Patients with a BMI between 16 and 40
- Patients who are skeletally mature
- Patients aged over 18 at the time of surgery
- Patients willing to return for follow-up evaluations
- Patients who have the ability to follow instructions
- Patients with sufficient bone stock and quality
Exclusion
- Female patients who are pregnant or planning pregnancy during the course of the study (no use of adequate birth control)
- Patients with diagnosed active infection
- Patients with marked bone loss which could preclude or compromise adequate fixation of the device
- Patients with Parkinson disease
- Patients using immunosuppressive drugs
- Patients with an immunosuppressive disease
- Patients with BMI \<16
- Patient with BMI \>40
- Patients who are unfit for surgery (ASA IV - V)
- Patients with acetabular or femoral osteotomy
- Patients who had a THA on the contralateral side within last 6 months
- Patients belonging to the vulnerable population: children, patients with mental
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02307331
Start Date
March 1 2014
End Date
September 2 2023
Last Update
September 6 2023
Active Locations (1)
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1
Deot of Orthopedics, Skane University Hospital, Lund University
Lund, Sweden, 221 85