REDAPT Revision Hip System With RSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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)

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hip revision

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

Group Type OTHER

Full revision

Intervention Type DEVICE

Both cup and stem require revision

Cup revision

Intervention Type DEVICE

Only the cup requires revision

Stem revision

Intervention Type DEVICE

Only the stem requires revision

Interventions

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Full revision

Both cup and stem require revision

Intervention Type DEVICE

Cup revision

Only the cup requires revision

Intervention Type DEVICE

Stem revision

Only the stem requires revision

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes