REDAPT Revision Hip System With RSA

Hip Osteoarthritis Clinical Trial

Official title:

Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04541693
• Other study ID #: B2018-092
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2023
• Source: Orthopaedic Innovation Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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:

1. femoral stem revision (n=30 hips)

2. acetabular cup revision (n=22 hips)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Full revision
Both cup and stem require revision
• Cup revision
Only the cup requires revision
• Stem revision
Only the stem requires revision

Locations

Country	Name	City	State
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic Innovation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-op: 2-week, 6-month, 1-year, 2-year
Primary	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.	Pre-op, Post-op (6 months, 1 year, and 2 years)
Primary	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.	Pre-op, Post-op (6 months, 1 year, and 2 years)
Primary	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)	Pre-op, Post-op (6 months, 1 year, and 2 years)
Primary	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).	Pre-op, Post-op (6 months, 1 year, and 2 years)
Secondary	Stem subsidence	Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem	1-year, 2-year