RSA Study of Sirius Stem and Exceed Cup

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Optivac; Device: Optipac; Device: E1 (Exceed cup); Device: Arcom (Exceed cup); Device: Sirius stem

• Registration Number: NCT02307331
• Lead 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.

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Primary Completion: 2020-08
• Status Verified: 2023-09
• Study Completion: 2023-09-02
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optivac and E1	E1 (Exceed cup)	Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE
Optivac and E1	Optivac	Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE
Optivac and E1	Sirius stem	Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE
Optivac and Arcom	Arcom (Exceed cup)	Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE
Optivac and Arcom	Optivac	Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE
Optivac and Arcom	Sirius stem	Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE
Optipac and E1	Optipac	Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE
Optipac and E1	E1 (Exceed cup)	Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE
Optipac and Arcom	Optipac	Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE
Optipac and Arcom	Arcom (Exceed cup)	Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE
Optipac and Arcom	Sirius stem	Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE

Primary Outcome Measures

Name	Time	Method
Radiostereometry (RSA) - change in migration and wear over time	First postoperative day, 3 months, 1 year, 2 years and 5 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Deot of Orthopedics, Skane University Hospital, Lund University; 🇸🇪 Lund, Sweden