Arcos Revision Stem: Evaluation of Clinical Performance

NCT01820611 | Completed Results

• 1 other identifier: GBMET.CR.US19
• Study Type: observational
• Target: 74
• Locations: 4 countries
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Survivorship

  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

  5 year post surgery

Secondary Outcomes (4)

• Radiographic Evaluation

  6 weeks, 1 year, 3 years and 5 years Post Surgery

• EQ5D

  Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery

• Oxford Hip Score

  Preop, 6 weeks, 1 year, 3 years and 5 years post surgery

• Harris Hip Score

  Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery

Study Arms (1)

With Bonemaster HA

100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite

Device: Arcos Revision Stem System

Interventions

Arcos Revision Stem System DEVICE

Revision Hip System

With Bonemaster HA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients who had a revision to a total hip replacement using the Arcos Revision Stem Hip System.

You may qualify if:

• 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.
• No age limit, however, the patient must have reached full skeletal maturity.
• Willing to return for follow up evaluation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Turku University Hospital

Turku, Finland

Location

Hospital Universitari Mutua

Barcelona, Spain

Location

Uddevalla Hospital

Uddevalla, Sweden

Location

Hinchingbrooke Hosptial

Cambridge, United Kingdom

Location

NHS - Sheffield Teaching Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Congenital Abnormalities; Fractures, Bone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Limitations and Caveats

The study was initially set up to collect data within two study arms (100 with BoneMaster HA and 100 without BoneMaster HA) globally including up to ten sites. However, the study only ended up enrolling 74 cases with BoneMaster in EMEA across 5 study sites.

Results Point of Contact

• Title: Linda Meijer
• Organization: Zimmer Biomet

linda.meijer@zimmerbiomet.com

+31 6 57933741

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 29, 2013
• Study Start: February 1, 2013
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2024-11

Locations

FI (1); SE (1); ES (1); GB (2)