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NCT Number: NCT04541693

REDAPT Revision Hip System With RSA

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full revision

Device

Both cup and stem require revision

Cup revision

Device

Only the cup requires revision

Stem revision

Device

Only the stem requires revision

Primary outcomes

  1. Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year

    Time frame: Post-op: 2-week, 6-month, 1-year, 2-year

    Stability over a period of two year measured by migration with Röntgen Stereometric Analysis

  2. Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year

    Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)

    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.

  3. Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year

    Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)

    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.

  4. Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year

    Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)

    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)

  5. Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year

    Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)

    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 outcomes

  1. Stem subsidence

    Time frame: 1-year, 2-year

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

Sponsors and collaborators

Lead sponsor

Orthopaedic Innovation Centre

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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