REDAPT Revision Hip System With RSA

Orthopaedic Innovation Centre

Status

Active, not recruiting

Conditions

Hip Osteoarthritis

Treatments

Device: Cup revision

Device: Full revision

Device: Stem revision

Study type

Interventional

Funder types

Other

Identifiers

NCT04541693

B2018-092

Details and patient eligibility

About

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).

Full 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)

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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