Clinical trial NCT02307331: RSA Study of Sirius Stem and Exceed Cup
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Hip Replacement
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2014-12-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 OptiPac/OptiVac bone cement mixing systems.

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 criterion for evaluation, but randomized into four groups for the evaluation of the secondary criteria for evaluation

The objectives of the study are to:

1. Demonstrate a comparable migration pattern as is described in published literature on other double tapered polished cemented stems
2. Measure wear pattern in the cup made of vitamin-E doped polyethylene or conventional Arcom polyethylene

2)Demonstrate non-inferiority of Optipac vs. Optivac cement mixing systems on the stem side 3)Evaluate the clinical outcome and survivorship of the implant

Eligibility criteria: 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

Primary outcomes:
measure: Radiostereometry (RSA) - change in migration and wear over time
timeFrame: First postoperative day, 3 months, 1 year, 2 years and 5 years
Secondary outcomes:
measure: Conventional Radiography (Signs of radiolucent lines or obvious change of position will be measured in mm)
timeFrame: First postoperative day, 2 years and 5 years
measure: HOOS (Hip specific health questionnaire)
timeFrame: Preoperatively, 1 year, 2 years and 5 years
measure: EQ5D
timeFrame: Preoperatively, 1 year, 2 years and 5 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Deot of Orthopedics, Skane University Hospital, Lund University
Study officials:
affiliation: Dept of Orthopedics, Skane University Hospital, Lund University
name: Gunnar Flivik, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: