RSA Study of Sirius Stem and Exceed Cup

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Optivac; Device: E1 (Exceed cup); Device: Sirius stem; Device: Arcom (Exceed cup); Device: Optipac

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
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 221 85
    • Deot of Orthopedics, Skane University Hospital, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Optivac and E1; Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE	Device: Optivac; A vacuum mixing system for cement with mixing and collection under vacuum but open initial mixture of powder and monomer. Has been used since 1993 with excellent results; Device: E1 (Exceed cup); The Exceed cup is available in two type of advanced bearing polyethylene material: The new is a highly cross linked polyethylene with infusion of vitamin E1 to remove free radicals in order to reduce wear.; Device: Sirius stem; A polished tapered stem
Other: Optivac and Arcom; Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE	Device: Optivac; A vacuum mixing system for cement with mixing and collection under vacuum but open initial mixture of powder and monomer. Has been used since 1993 with excellent results; Device: Sirius stem; A polished tapered stem; Device: Arcom (Exceed cup); The Exceed cup is available in two type of advanced bearing polyethylene material: The first is the 'classic', long term proven ArCom, a conventional polyethylene
Other: Optipac and E1; Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE	Device: E1 (Exceed cup); The Exceed cup is available in two type of advanced bearing polyethylene material: The new is a highly cross linked polyethylene with infusion of vitamin E1 to remove free radicals in order to reduce wear.; Device: Optipac; A vacuum mixing system for cement with mixing and collection under vacuum but with a pre-packed mixing system allowing for an all closed system minimizing exposure for monomer fumes. This is a relatively new mixing system
Other: Optipac and Arcom; Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE	Device: Sirius stem; A polished tapered stem; Device: Arcom (Exceed cup); The Exceed cup is available in two type of advanced bearing polyethylene material: The first is the 'classic', long term proven ArCom, a conventional polyethylene; Device: Optipac; A vacuum mixing system for cement with mixing and collection under vacuum but with a pre-packed mixing system allowing for an all closed system minimizing exposure for monomer fumes. This is a relatively new mixing system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiostereometry (RSA) - change in migration and wear over time	Prosthesis migration and cup wear are measured over time, from baseline directly postop up to 5years. Measures are given in change in mm (translation) and degrees (rotation) around x, y and z-axis.	First postoperative day, 3 months, 1 year, 2 years and 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conventional Radiography (Signs of radiolucent lines or obvious change of position will be measured in mm)	Signs of radiolucent lines or obvious change of position will be measured in mm	First postoperative day, 2 years and 5 years
HOOS (Hip specific health questionnaire)	Hip specific health questionnaire - HOOS	Preoperatively, 1 year, 2 years and 5 years
EQ5D	General health questionnaire - EQ-5D	Preoperatively, 1 year, 2 years and 5 years

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Gunnar Flivik, Md PhD, Dept of Orthopedics, Skane University Hospital, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): September 2, 2023

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimated): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Total Hip Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Sirius RSA study_JT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO