Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Total Hip Arthroplasty

Treatments: Procedure: Total Hip Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01566916

RIFJPAR 12-01

Details and patient eligibility

About

This prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient signed an IRB, study specific informed patient consent
• Patient is a male or non-pregnant female age 21 years or older at the time of study device implantation
• Patient has primary diagnosis of non-inflammatory degenerative joint disease.
• Patient is a candidate for primary cementless total hip replacement
• Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

• Patient has a Body Mass Index (BMI) > 40 Kg/m2
• Patient has an active or suspected infection at the time of device implantation
• Patient is immunologically suppressed.
• Patient requires revision surgery of a previously implanted total hip replacement
• Patient has a known sensitivity to device materials

Trial design

0 participants in 2 patient groups

Total Hip Arthroplasty performed via direct anterior approach

Active Comparator group

Treatment:

Procedure: Total Hip Arthroplasty

Total Hip Arthroplasty using anterolateral approach

Active Comparator group

Treatment:

Procedure: Total Hip Arthroplasty