Clinical trial NCT01820611: Arcos Revision Stem: Evaluation of Clinical Performance
Official title: Arcos Revision Stem: Evaluation of Clinical Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Deformity
Fracture
Complications; Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Survivorship
timeFrame: 5 year post surgery
Secondary outcomes:
measure: Radiographic Evaluation
timeFrame: 6 weeks, 1 year, 3 years and 5 years Post Surgery
measure: EQ5D
timeFrame: Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery
measure: Oxford Hip Score
timeFrame: Preop, 6 weeks, 1 year, 3 years and 5 years post surgery
measure: Harris Hip Score
timeFrame: Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari Mutua
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Cambridge
country: United Kingdom
facility: Hinchingbrooke Hosptial
city: Sheffield
country: United Kingdom
facility: NHS - Sheffield Teaching Hospital
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: