Clinical trial NCT02851992: A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Official title: A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.

Detailed description: The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements.

The initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Eligibility criteria: Inclusion Criteria:

Patients inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically

* Primary osteoarthritis or secondary coxarthritis
* Inflammation of the hip: rheumatoid arthritis, etc.
* Femoral neck fracture
* Avascular necroses of the femoral head
* Sequelae from previous operations on the hip, osteotomies, etc.
* Congenital hip dysplasia

Additional inclusion criteria include:

* 18 years of age or older
* Subjects willing to return for follow-up evaluations
* Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements)

Exclusion Criteria:

Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem

Absolute contraindications include:

* Local or systemic infections.
* Severe muscular, neurological or vascular deficiencies of the extremity involved
* Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)
* Concomitant disease likely to affect implant function
* Allergy to any of the components of the implant
* Patients weighing more than 110 kg

Additional exclusion criteria:

* Subjects unable to co-operate with and complete the study
* Dementia and/or inability to understand and follow instructions
* Neurological conditions affecting movement
* Patient over 18 under law supervision

Primary outcomes:
measure: Mean Harris Hip Score
timeFrame: pre-operatively and 2 years post-operatively
Secondary outcomes:
measure: Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
timeFrame: 1 year post-operatively
measure: Patient Satisfaction
timeFrame: pre-operatively and 2 years post-operatively
measure: Adverse Events/Complications
timeFrame: until 2 years post-operatively
measure: Survivorship
timeFrame: at 2 years post-op
Other outcomes:
Locations:
Study officials:
References: