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NCT02307331 | COMPLETED | Osteoarthritis

RSA Study of Sirius Stem and Exceed Cup
Sponsor:

Region Skane

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.

Condition or disease

Osteoarthritis

Intervention/treatment

Optivac

Optipac

Arcom (Exceed cup)

E1 (Exceed cup)

Sirius stem

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : SINGLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2014-03
Estimated Primary Completion Date : 2020-08
Estimated Study Completion Date : 2023-09-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
RSA Study of Sirius Stem and Exceed Cup

Location Details

NCT02307331

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Sweden,

Deot of Orthopedics, Skane University Hospital, Lund University

Lund, Sweden, 221 85