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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 September 2023 |
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Main ID: |
NCT02307331 |
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Date of registration:
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25/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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RSA Study of Sirius Stem and Exceed Cup
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Scientific title:
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RCT of the Sirius Stem Used in Conjunction With the Exceed ABT Cemented Cup and OptiPac/OptiVac Cement - Model Based RSA, Clinical and Radiographic Outcomes |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02307331 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Gunnar Flivik, Md PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept of Orthopedics, Skane University Hospital, Lund University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients who are eligible for cemented total hip arthroplasty
2. Patients diagnosed with primary Osteoarthritis
3. Patients who are fit for elective surgery (ASA I - III)
4. Patients with a BMI between 16 and 40
5. Patients who are skeletally mature
6. Patients aged over 18 at the time of surgery
7. Patients willing to return for follow-up evaluations
8. Patients who have the ability to follow instructions
9. Patients with sufficient bone stock and quality
Exclusion Criteria:
1. Female patients who are pregnant or planning pregnancy during the course of the study
(no use of adequate birth control)
2. Patients with diagnosed active infection
3. Patients with marked bone loss which could preclude or compromise adequate fixation of
the device
4. Patients with Parkinson disease
5. Patients using immunosuppressive drugs
6. Patients with an immunosuppressive disease
7. Patients with BMI <16
8. Patient with BMI >40
9. Patients who are unfit for surgery (ASA IV - V)
10. Patients with acetabular or femoral osteotomy
11. Patients who had a THA on the contralateral side within last 6 months
12. Patients belonging to the vulnerable population: children, patients with mental
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Device: Sirius stem
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Device: Optipac
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Device: Optivac
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Device: Arcom (Exceed cup)
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Device: E1 (Exceed cup)
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Primary Outcome(s)
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Radiostereometry (RSA) - change in migration and wear over time
[Time Frame: First postoperative day, 3 months, 1 year, 2 years and 5 years]
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Secondary Outcome(s)
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HOOS (Hip specific health questionnaire)
[Time Frame: Preoperatively, 1 year, 2 years and 5 years]
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Conventional Radiography (Signs of radiolucent lines or obvious change of position will be measured in mm)
[Time Frame: First postoperative day, 2 years and 5 years]
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EQ5D
[Time Frame: Preoperatively, 1 year, 2 years and 5 years]
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Secondary ID(s)
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Sirius RSA study_JT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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