REDAPT Revision Hip System With RSA

NCT04541693 | Active Not Recruiting FDA Device

• 1 other identifier: B2018-092
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• 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

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Stem subsidence

  1-year, 2-year

Study Arms (1)

Hip revision

OTHER

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

Device: Full revision; Device: Cup revision; Device: Stem revision

Interventions

Full revision DEVICE

Both cup and stem require revision

Hip revision

Cup revision DEVICE

Only the cup requires revision

Hip revision

Stem revision DEVICE

Only the stem requires revision

Hip revision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopaedic Innovation Centre: lead

Study Sites (1)

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Turgeon, MD

  Concordia Joint Replacement Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 9, 2020
• Study Start: January 15, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

CA (1)