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Cup Position in THA With Standard Instruments

2017-06-19 02:51:52 | BioPortfolio

Summary

Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6, 12 and 52 weeks postoperatively.

Description

This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows:

Primary endpoint:

The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.

Secondary endpoints:

1. Inclination success (as defined for the primary endpoint)

2. Version success (as defined for the primary endpoint)

3. 90-day complication rates

4. Change from preoperative baseline for the Harris Hip Score

5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)

6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable)

7. Change from 6 week baseline for the Forgotten Joint Score

Study Design

Conditions

Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

Intervention

Primary Uncemented Total Hip Arthroplasty

Status

Not yet recruiting

Source

DePuy Orthopaedics

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-06-19T02:51:52-0400

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