RSA Study of Sirius Stem and Exceed Cup

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307331
• Other study ID #: Sirius RSA study_JT
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2, 2023

Study information

• Verified date: September 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2, 2023
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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
• 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
• 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
• 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.
• Sirius stem
A polished tapered stem

Locations

Country	Name	City	State
Sweden	Deot of Orthopedics, Skane University Hospital, Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Zimmer Biomet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	HOOS (Hip specific health questionnaire)	Hip specific health questionnaire - HOOS	Preoperatively, 1 year, 2 years and 5 years
Secondary	EQ5D	General health questionnaire - EQ-5D	Preoperatively, 1 year, 2 years and 5 years