Excia T Cementless EBRA Study

NCT02799654 | Withdrawn

• 1 other identifier: AAG-O-H-1612
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the first 24 months evaluated.

Conditions

Arthritis, Degenerative; Arthritis, Rheumatoid; Hip Fractures; Femur Head Necrosis

Keywords

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Subsidence over time of Excia T® stem (EBRA-FCA)

  The subsidence of the Excia T stem will be measured with Ein-Bild-Röntgen-Analysis Femoral Component Analysis (EBRA-FCA). EBRA allows a non-invasive measurement of routinely taken A/P radiographs. Necessary is a series of at least four x-rays that can be read by the EBRA software. The whole implant must be visible on the A/P x-ray, as well as the greater and lesser trochanter. Subsidence shall be measured on the follow-up x-rays in comparison to the discharge x-rays.

  discharge (approx. 1 week postop), 3, 12 and 24 months postoperative

Secondary Outcomes (8)

• Clinical Results over time (Harris Hip Score)

  preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative

• Quality of Life over time (EQ-5D-5L)

  preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative

• Osteolysis over time (localized bone resorption)

  3, 12 and 24 months postoperative

• Radiolucent lines over time

  3, 12 and 24 months postoperative

• Cortical thinning

  3, 12 and 24 months postoperative

Eligibility Criteria

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

Study Population

Patients with indication for cementless primary Total Hip Arthroplasty

You may qualify if:

• Written patient consent to study participation
• Age \> 18 years
• Indication for primary THA with cementless Excia T® stem

You may not qualify if:

• Pregnancy
• THA after fracture
• Rheumatoid arthritis
• Systemic disorders, treated with Cortisone or other pharmaceuticals, potentially compromising the bone quality
• Patient physically or mentally not able to follow the postoperative examination routine

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Prof. Dr. med. E. Mayr

Celle, 29223, Germany

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Hip Fractures; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 15, 2016
• Study Start: August 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)