A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem

Not Applicable

Active, not recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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

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:

Arm && Interventions

Group	Intervention	Description
GTS cementless stem	GTS cementless stem	Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)

Primary Outcome Measures

Name	Time	Method
Mean Harris Hip Score	pre-operatively and 2 years post-operatively	Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.

Secondary Outcome Measures

Name	Time	Method
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling	1 year post-operatively	The presence or absence of the following femoral radiographic findings were reported: subsidence of the stem, stem radiolucencies, calcar resorption, heterotopic ossification.
Survivorship	at 2 years post-op	Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 2 years post-operative is presented here.
Patient Satisfaction	pre-operatively and 2 years post-operatively	EQ-5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic. The EQ-5D is a standardized instrument widely used to measure health status. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. Scores will be within the range of 0-1 with 1 corresponding to perfect health.
Adverse Events/Complications	until 2 years post-operatively	The number of revisions/removals, device-related SAE's and deaths are listed.