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REDAPT Revision Hip System With RSA

Primary Purpose

Hip Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Full revision
Cup revision
Stem revision
Sponsored by
Orthopaedic Innovation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised
  • Ability to use study device (not requiring specialized implants)
  • Patients between the ages of 18+ older
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

Exclusion Criteria:

  • Acute infection requiring washout, debridement, and liner exchange
  • Unresolved infection
  • Undergoing stage 1 of a 2-stage revision for infection
  • Known metal allergy to device components
  • Active participation in another clinical study (within the past 30 days)
  • Known risk for loss to follow-up (significant geographical distance from treatment centre)
  • BMI>40 (severe obesity)
  • Unable to provide informed consent (cognitive impairment)
  • Patients requiring a bearing couple different than metal on polyethylene
  • Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length)
  • Patients with severe defects, dysplasia, or tumor
  • Inflammatory joint disease

Sites / Locations

  • Concordia Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hip revision

Arm Description

Revision to cup and stem, cup only or stem only.

Outcomes

Primary Outcome Measures

Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year
Stability over a period of two year measured by migration with Röntgen Stereometric Analysis
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)
Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year
Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5).

Secondary Outcome Measures

Stem subsidence
Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem

Full Information

First Posted
August 31, 2020
Last Updated
June 26, 2023
Sponsor
Orthopaedic Innovation Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04541693
Brief Title
REDAPT Revision Hip System With RSA
Official Title
Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopaedic Innovation Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).
Detailed Description
This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are: femoral stem revision (n=30 hips) acetabular cup revision (n=22 hips)

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hip revision
Arm Type
Other
Arm Description
Revision to cup and stem, cup only or stem only.
Intervention Type
Device
Intervention Name(s)
Full revision
Intervention Description
Both cup and stem require revision
Intervention Type
Device
Intervention Name(s)
Cup revision
Intervention Description
Only the cup requires revision
Intervention Type
Device
Intervention Name(s)
Stem revision
Intervention Description
Only the stem requires revision
Primary Outcome Measure Information:
Title
Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year
Description
Stability over a period of two year measured by migration with Röntgen Stereometric Analysis
Time Frame
Post-op: 2-week, 6-month, 1-year, 2-year
Title
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
Description
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.
Time Frame
Pre-op, Post-op (6 months, 1 year, and 2 years)
Title
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
Description
The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Time Frame
Pre-op, Post-op (6 months, 1 year, and 2 years)
Title
Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year
Description
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)
Time Frame
Pre-op, Post-op (6 months, 1 year, and 2 years)
Title
Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year
Description
Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5).
Time Frame
Pre-op, Post-op (6 months, 1 year, and 2 years)
Secondary Outcome Measure Information:
Title
Stem subsidence
Description
Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem
Time Frame
1-year, 2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised Ability to use study device (not requiring specialized implants) Patients between the ages of 18+ older Patients willing and able to comply with follow-up requirements and self-evaluations Ability to give informed consent Exclusion Criteria: Acute infection requiring washout, debridement, and liner exchange Unresolved infection Undergoing stage 1 of a 2-stage revision for infection Known metal allergy to device components Active participation in another clinical study (within the past 30 days) Known risk for loss to follow-up (significant geographical distance from treatment centre) BMI>40 (severe obesity) Unable to provide informed consent (cognitive impairment) Patients requiring a bearing couple different than metal on polyethylene Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length) Patients with severe defects, dysplasia, or tumor Inflammatory joint disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD
Organizational Affiliation
Concordia Joint Replacement Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concordia Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada

12. IPD Sharing Statement

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REDAPT Revision Hip System With RSA

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