A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads (X3largeheads)

A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads With Highly Cross Linked (X3) Acetabular Polyethylene Insert in the Hemispherical Trident Cup

Prospective, single centre, randomized clinical study; series of patients with a 5-years patient evaluation period.

Study Overview

• Status: Terminated
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Trident cup, X3 inserts, 28 mm head; Device: Symax stem; Device: Accolade TMZF stem; Device: Trident cup, X3 inserts, 40 mm head

Detailed Description

This is a single centre randomized clinical outcomes study. The Symax stem or Accolade TMZF (Titan, Molybdenum, Zirconium, Ferrum) in combination with the Hemispherical Trident cup, X3 inserts, 28 and 40 mm Metal heads are the primary components to be implanted for evaluation.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Heerlen, Netherlands
    • Atrium Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and non pregnant female patients between 18-75 years of age.
2. Patients requiring uncemented primary total hip arthroplasty (THA), suitable for the use of the Symax stem
3. Patients with a diagnosis of osteoarthritis (OA), rheumatoid arthritis (RA), avascular necrosis (AVN) or post-traumatic arthritis (TA).
4. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
5. Patients who signed the specific Informed Consent Form prior to surgery

Exclusion Criteria:

1. Patients who require revision of a previously implanted THA
2. Patients who had a THA on contra-lateral side within the last 1 year.
3. Patients who had a THA on contralateral side more than 1 year ago and the rehabilitation period outcome was considered unsatisfactory or not good. (Patients with contra-lateral THA > 1 year ago with good outcome (Harris Hip Score > 85) can be included in the study).
4. Patients who will need lower limb joint replacement for another joint within one year.
5. Bilaterally operated patient.
6. Patients who have had a prior procedure of acetabular osteotomy.
7. Patients with active or suspected infection.
8. Patients with malignancy - active malignancy
9. Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
10. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
11. Female patients planning a pregnancy during the course of the study.
12. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
13. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
14. Patients with other severe concurrent joint involvements which can affect their outcome.
15. Patients with other concurrent illnesses which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus, psoriasis, Insulin dependent Type I diabetes or renal disease requiring dialysis.
16. Surgeries to be performed with navigation and/or robot-assisted instruments.
17. Patient with a known sensitivity to device materials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trident cup, X3 inserts, 28 mm head; Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.	Device: Trident cup, X3 inserts, 28 mm head; Orthopaedic implant; Device: Symax stem; Orthopaedic implant; Device: Accolade TMZF stem; Orthopaedic implant
Active Comparator: Trident cup, X3 inserts, 40 mm head; Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.	Device: Symax stem; Orthopaedic implant; Device: Accolade TMZF stem; Orthopaedic implant; Device: Trident cup, X3 inserts, 40 mm head; Orthopaedic implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS).	Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.	5 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS) Patient Questionnaire	Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor.	6 weeks, 3 months, 1, 2 and 5 years
Merle D'Aubergine Score (MdA)	The Merle D'Aubergine-Charnley Score is a simplified clinical scoring system for the hip. The overall score is determined by the sum of scores obtained from each dimension of pain, walking ability and joint mobility. The overall numeric score is given by adding the domain scores. Clinical grades: Excellent, 18, Good 15-17, Fair 13-14, Poor <13.	6 weeks, 3 months, 1, 2 and 5 years

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Ide C. Heyligers, MD, Atrium Medical Center, Heerlen, The Netherlands

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 12, 2016
• Study Completion (Actual): January 12, 2016

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimated): August 17, 2015

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H-S-045