N/A
Completed N=74
Arcos Revision Stem: Evaluation of Clinical Performance
Source: ClinicalTrials.gov NCT01820611 ↗Enrolled (actual)
74
Serious AEs
37.8%
Results posted
Jan 2025
Primary outcomePrimary: Survivorship — 74 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survivorship |
74 | — |
| SECONDARY Radiographic Evaluation |
9; 4; 1; 12; 5; 8 | — |
| SECONDARY EQ5D |
0.3; 0.6; 0.7; 0.7; 0.8 | — |
| SECONDARY Oxford Hip Score |
18.8; 28.3; 34.4; 36.9; 39.3 | — |
| SECONDARY Harris Hip Score |
41.3; 60.0; 73.0; 78.3; 79.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01820611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.