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

NCT02851992 | Active Not Recruiting Results

• 1 other identifier: ORTHO.CR.H36
• Study Type: interventional
• Target: 303
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling

  1 year post-operatively

• Patient Satisfaction

  pre-operatively and 2 years post-operatively

• Adverse Events/Complications

  until 2 years post-operatively

• Survivorship

  at 2 years post-op

Study Arms (1)

GTS cementless stem

OTHER

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

Device: GTS cementless stem

Interventions

GTS cementless stem DEVICE

Total Hip Arthroplasty

GTS cementless stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Lisette Smid, Clinical Project Lead
• Organization: Zimmer Biomet

lisette.smid@zimmerbiomet.com

+31 62 395 6378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 2, 2016
• Study Start: September 1, 2012
• Primary Completion: December 1, 2020
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share