Arcos Revision Stem: Evaluation of Clinical Performance

Rheumatoid Arthritis Clinical Trial

Official title:

Arcos Revision Stem: Evaluation of Clinical Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820611
• Other study ID #: GBMET.CR.US19
• Status: Completed
• Start date: February 2013
• Est. completion date: June 14, 2021

Study information

• Verified date: July 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis
• Complications; Arthroplasty
• Deformity
• Fracture
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Arcos Revision Stem System
Revision Hip System

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku
Spain	Hospital Universitari Mutua	Barcelona
Sweden	Uddevalla Hospital	Uddevalla
United Kingdom	Hinchingbrooke Hosptial	Cambridge
United Kingdom	NHS - Sheffield Teaching Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Finland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship & Revision Rate	Survivorship & Revision Rate	5 year follow-up
Secondary	Stability and Fixation of Arcos Hip by radiographic assessment	Stability and Fixation of Arcos Hip by radiographic assessment	5 year follow-up
Secondary	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
Secondary	Oxford Hip Score	Oxford Hip Score - patient reported outcome measurement	5 year follow-up
Secondary	Harris Hip Score	Harris Hip Score - patient reported outcome measurement	5 year follow-up
Secondary	Adverse Events	Adverse Events	5 year follow-up