Arcos Revision Stem: Evaluation of Clinical Performance

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bone defect level and the success of the Arcos Stem.

Detailed Description
-----------------
Primary Endpoint: survivorship and revision rate up to 5 years post-operatively Secondary Endpoints: Stability and Fixation of Arcos Hip by radiographic assessment, Relationship between bone defect level and survivorship, Oxford Hip Score and Harris Hip Score post-operative, Adverse events, complications. Case Report Forms: Demographic Data, Paprosky Acetabular/Femoral Defects, Operative Data, Oxford Hip Score, Harris Hip Score, Collection of X-rays, Radiographic Evaluation form, Adverse Events, Revisions, Lost to Follow-up, and Protocol Deviations 200 patients: 100 with BoneMaster HA, 100 without BoneMaster HA. Up to 10 sites globally will be used to fulfill enrollment in this study. All cases enrolled will be those implanted with either the Cone, Broached, or Calcar Proximal Body and one of the five distal options (Slotted, Bullet-tip, Interlocking, STS, or ETO). To be included in the study, a patient must have received a revision total hip arthroplasty with the Arcos system. The Arcos system is to be used in accordance to the indications for use and contraindications detailed in the approved labeling of the device. Study time perspective: Collection of retrospective data in supplement to the data collected in the course of the prospective study to compensate total enrolment goal. This is applicable for 3 sites: Finland, United Kingdom (NHS Sheffield), Spain. All patients enrolled in the study will be followed up as tot he same time points for the duration of the study.

Official Title
-----------------
Arcos Revision Stem: Evaluation of Clinical Performance

Conditions
-----------------
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Deformity, Fracture, Complications; Arthroplasty

Intervention / Treatment
-----------------
* Device: Arcos Revision Stem System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. Revision of previously failed total hip arthroplasty. The Arcos™ Modular Femoral Revision System hip components are single-use implants, intended for uncemented use only. Only subjects who have received or have already been scheduled to receive hip surgery with the Arcos Revision Stem System will be included in this outcomes study. Additional Inclusion Criteria: No age limit, however, the patient must have reached full skeletal maturity. Willing to return for follow up evaluation. Exclusion Criteria: Absolute contraindications include: active infection, sepsis, and osteomyelitis. Relative contraindications include: Uncooperative patient or patient with neurologic disorders who are incapable of following directions Osteoporosis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy, or neuromuscular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With Bonemaster HA<br>100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite | Device: Arcos Revision Stem System<br>* Revision Hip System<br>|
| Without BoneMaster HA<br>100 patients using Arcos Revision Stem System without BoneMaster Hydroxyapatite | Device: Arcos Revision Stem System<br>* Revision Hip System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship & Revision Rate | Survivorship & Revision Rate | 5 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability and Fixation of Arcos Hip by radiographic assessment | Stability and Fixation of Arcos Hip by radiographic assessment | 5 year follow-up | 
| Relationship between bone defect level and survivorship | Before surgery, the Paprsoky Classification will be used to determine the femoral and acetabular defect level in order to create a baseline measurement that will then be used for making comparisons and analyzing outcomes in terms of survivorship. | 5 year follow-up | 
| Oxford Hip Score | Oxford Hip Score - patient reported outcome measurement | 5 year follow-up | 
| Harris Hip Score | Harris Hip Score - patient reported outcome measurement | 5 year follow-up | 
| Adverse Events | Adverse Events | 5 year follow-up |