Back to results

RSA Study of Sirius Stem and Exceed Cup

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Optivac

Optipac

Arcom (Exceed cup)

E1 (Exceed cup)

Sirius stem

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total Hip Replacement

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients who are eligible for cemented total hip arthroplasty
Patients diagnosed with primary Osteoarthritis
Patients who are fit for elective surgery (ASA I - III)
Patients with a BMI between 16 and 40
Patients who are skeletally mature
Patients aged over 18 at the time of surgery
Patients willing to return for follow-up evaluations
Patients who have the ability to follow instructions
Patients with sufficient bone stock and quality

Exclusion Criteria:

Female patients who are pregnant or planning pregnancy during the course of the study (no use of adequate birth control)
Patients with diagnosed active infection
Patients with marked bone loss which could preclude or compromise adequate fixation of the device
Patients with Parkinson disease
Patients using immunosuppressive drugs
Patients with an immunosuppressive disease
Patients with BMI <16
Patient with BMI >40
Patients who are unfit for surgery (ASA IV - V)
Patients with acetabular or femoral osteotomy
Patients who had a THA on the contralateral side within last 6 months
Patients belonging to the vulnerable population: children, patients with mental

Sites / Locations

Deot of Orthopedics, Skane University Hospital, Lund University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Optivac and E1

Optivac and Arcom

Optipac and E1

Optipac and Arcom

Arm Description

Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE

Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE

Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE

Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

HOOS (Hip specific health questionnaire)

Hip specific health questionnaire - HOOS

EQ5D

General health questionnaire - EQ-5D

Full Information

NCT ID

NCT02307331

First Posted

November 25, 2014

Last Updated

September 4, 2023

Sponsor

Region Skane

Collaborators

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT02307331

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

August 2020 (Actual)

Study Completion Date

September 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

Collaborators

Zimmer Biomet

4. Oversight

Data Monitoring Committee

5. Study Description

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: Demonstrate a comparable migration pattern as is described in published literature on other double tapered polished cemented stems 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Total Hip Replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Optivac and E1

Arm Type

Other

Arm Description

Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE

Arm Title

Optivac and Arcom

Arm Type

Other

Arm Description

Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE

Arm Title

Optipac and E1

Arm Type

Other

Arm Description

Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE

Arm Title

Optipac and Arcom

Arm Type

Other

Arm Description

Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE

Intervention Type

Device

Intervention Name(s)

Optivac

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Optipac

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Arcom (Exceed cup)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

E1 (Exceed cup)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sirius stem

Intervention Description

A polished tapered stem

Primary Outcome Measure Information:

Title

Radiostereometry (RSA) - change in migration and wear over time

Description

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.

Time Frame

First postoperative day, 3 months, 1 year, 2 years and 5 years

Secondary Outcome Measure Information:

Title

Conventional Radiography (Signs of radiolucent lines or obvious change of position will be measured in mm)

Description

Signs of radiolucent lines or obvious change of position will be measured in mm

Time Frame

First postoperative day, 2 years and 5 years

Title

HOOS (Hip specific health questionnaire)

Description

Hip specific health questionnaire - HOOS

Time Frame

Preoperatively, 1 year, 2 years and 5 years

Title

EQ5D

Description

General health questionnaire - EQ-5D

Time Frame

Preoperatively, 1 year, 2 years and 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who are eligible for cemented total hip arthroplasty Patients diagnosed with primary Osteoarthritis Patients who are fit for elective surgery (ASA I - III) Patients with a BMI between 16 and 40 Patients who are skeletally mature Patients aged over 18 at the time of surgery Patients willing to return for follow-up evaluations Patients who have the ability to follow instructions Patients with sufficient bone stock and quality Exclusion Criteria: Female patients who are pregnant or planning pregnancy during the course of the study (no use of adequate birth control) Patients with diagnosed active infection Patients with marked bone loss which could preclude or compromise adequate fixation of the device Patients with Parkinson disease Patients using immunosuppressive drugs Patients with an immunosuppressive disease Patients with BMI <16 Patient with BMI >40 Patients who are unfit for surgery (ASA IV - V) Patients with acetabular or femoral osteotomy Patients who had a THA on the contralateral side within last 6 months Patients belonging to the vulnerable population: children, patients with mental

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gunnar Flivik, Md PhD

Organizational Affiliation

Dept of Orthopedics, Skane University Hospital, Lund University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deot of Orthopedics, Skane University Hospital, Lund University

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

RSA Study of Sirius Stem and Exceed Cup

We'll reach out to this number within 24 hrs