Arcos Revision Stem: Evaluation of Clinical Performance

Completed

Conditions: Rheumatoid Arthritis
Deformity
Fracture
Complications; Arthroplasty
Osteoarthritis
Avascular Necrosis

Interventions: Device: Arcos Revision Stem System

Registration Number: NCT01820611

Lead Sponsor: Zimmer Biomet

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 to the same time points for the duration of the study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With Bonemaster HA	Arcos Revision Stem System	100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Without BoneMaster HA	Arcos Revision Stem System	100 patients using Arcos Revision Stem System without BoneMaster Hydroxyapatite

Primary Outcome Measures

Name	Time	Method
Survivorship	5 year post surgery	The primary endpoint for this study was implant survival at 5 years post surgery and is presented by the number of cases with the implants unrevised

Secondary Outcome Measures

Name	Time	Method
Radiographic Evaluation	6 weeks, 1 year, 3 years and 5 years Post Surgery	This outcome measure was to evaluate the stability and fixation of the Arcos hip stem. This was done through radiographic measurements of stability and fixation, outcome, incidence of radiolucencies around the stem. Acetabular radiolucency was also assessed.
EQ5D	Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery	The EuroQol 5 Dimension (EQ-5D) is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, selfcare, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health.
Oxford Hip Score	Preop, 6 weeks, 1 year, 3 years and 5 years post surgery	The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The Score ranges from 0 - 100 and the outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27.
Harris Hip Score	Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery	The Harris hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care Professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). The total score can vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.

Trial Locations

Locations (5): Turku University Hospital
🇫🇮
Turku, Finland
NHS - Sheffield Teaching Hospital
🇬🇧
Sheffield, United Kingdom
Uddevalla Hospital
🇸🇪
Uddevalla, Sweden
Hospital Universitari Mutua
🇪🇸
Barcelona, Spain
Hinchingbrooke Hosptial
🇬🇧
Cambridge, United Kingdom