Mini Stem DEXA (Dual Energy X-ray Absorptiometry) (MISDexa)

Smith & Nephew

Status: Completed

Conditions: Osteoarthritis, Hip

Study type: Observational

Funder types: Industry

Identifiers

NCT01066936

2090SMFH131

Details and patient eligibility

About

The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

Full description

The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has hip disease that requires a total hip arthroplasty.
• Patient is willing to consent to participate in the study.
• Patient plans to be available for the study duration.
• Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.

Exclusion criteria

• Patient known to have insufficient bone stock.
• Patient has had major non-arthroscopic surgery to the study hip.
• Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
• Patient has a known sensitivity to materials in the device.