Restoration® Modular Revision Hip System Post Market Study

Not Applicable

Completed

Brief Summary: The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Detailed Description: The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.

Recruitment & Eligibility

Inclusion Criteria

Candidates for cementless revision of a failed femoral prosthesis.
Patients willing to sign the informed consent.
Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Restoration® Modular	Restoration® Modular Revision Hip System	All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.

Primary Outcome Measures

Name	Time	Method
Femoral Stem Fracture	5 years
Stem Survivorship (%)	5 years	Failure is defined by stem revision for any cause.

Secondary Outcome Measures

Name	Time	Method
Radiographic Stability	5 years	Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.
Post-surgery Femoral Crack/Fracture and Subsidence Rate	Post-op to 5 years
Harris Hip Score	pre-op and 5 years	Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor
SF-36 Health Status Survey: Role - Physical	pre-op, 2 year and 5 year	Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the "Role-Physical" score.

Locations (13): Crystal Clinic
🇺🇸
Akron, Ohio, United States
Iowa Orthopaedic Center
🇺🇸
Des Moines, Iowa, United States
Scott and White Hospital
🇺🇸
Temple, Texas, United States
Hospital for Joint Diseases
🇺🇸
New York, New York, United States
Providence Orthopaedic Specialities
🇺🇸
Spokane, Washington, United States
Beth Israel Medical Center
🇺🇸
New York, New York, United States
Orthopaedic Specialty Institute
🇺🇸
Orange, California, United States
New West Sports Medicine and Orthopaedic Surgery
🇺🇸
Kearney, Nebraska, United States
Rothman Institute
🇺🇸
Philadelphia, Pennsylvania, United States
Orthopedic Associates of Corpus Christi
🇺🇸
Corpus Christi, Texas, United States
Kansas Joint and Spine Institute
🇺🇸
Wichita, Kansas, United States
Jewish Hospital Center for Advanced Medicine
🇺🇸
Louisville, Kentucky, United States
Providence Portland Medical Center
🇺🇸
Portland, Oregon, United States