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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02851992
• Other study ID #: ORTHO.CR.H36
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2028

Study information

• Verified date: November 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 303
• Est. completion date: September 2028
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• GTS cementless stem
Total Hip Arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Harris Hip Score	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.	pre-operatively and 2 years post-operatively
Secondary	Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling	The presence or absence of the following femoral radiographic findings were reported: subsidence of the stem, stem radiolucencies, calcar resorption, heterotopic ossification.	1 year post-operatively
Secondary	Patient Satisfaction	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.	pre-operatively and 2 years post-operatively
Secondary	Adverse Events/Complications	The number of revisions/removals, device-related SAE's and deaths are listed.	until 2 years post-operatively
Secondary	Survivorship	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.	at 2 years post-op