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

NCT02525627 | Terminated Results

• 1 other identifier: H-S-045
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Harris Hip Score (HHS) Patient Questionnaire

  6 weeks, 3 months, 1, 2 and 5 years

• Merle D'Aubergine Score (MdA)

  6 weeks, 3 months, 1, 2 and 5 years

Study Arms (2)

Trident cup, X3 inserts, 28 mm head

ACTIVE COMPARATOR

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; Device: Symax stem; Device: Accolade TMZF stem

Trident cup, X3 inserts, 40 mm head

ACTIVE COMPARATOR

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, 40 mm head; Device: Symax stem; Device: Accolade TMZF stem

Interventions

Trident cup, X3 inserts, 28 mm head DEVICE

Orthopaedic implant

Trident cup, X3 inserts, 28 mm head

Trident cup, X3 inserts, 40 mm head DEVICE

Orthopaedic implant

Trident cup, X3 inserts, 40 mm head

Symax stem DEVICE

Orthopaedic implant

Trident cup, X3 inserts, 28 mm head; Trident cup, X3 inserts, 40 mm head

Accolade TMZF stem DEVICE

Orthopaedic implant

Trident cup, X3 inserts, 28 mm head; Trident cup, X3 inserts, 40 mm head

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non pregnant female patients between 18-75 years of age.
• Patients requiring uncemented primary total hip arthroplasty (THA), suitable for the use of the Symax stem
• Patients with a diagnosis of osteoarthritis (OA), rheumatoid arthritis (RA), avascular necrosis (AVN) or post-traumatic arthritis (TA).
• 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
• Patients who signed the specific Informed Consent Form prior to surgery

You may not qualify if:

• Patients who require revision of a previously implanted THA
• Patients who had a THA on contra-lateral side within the last 1 year.
• 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).
• Patients who will need lower limb joint replacement for another joint within one year.
• Bilaterally operated patient.
• Patients who have had a prior procedure of acetabular osteotomy.
• Patients with active or suspected infection.
• Patients with malignancy - active malignancy
• 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.
• 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.
• Female patients planning a pregnancy during the course of the study.
• Patients with systemic or metabolic disorders leading to progressive bone deterioration.
• 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.
• Patients with other severe concurrent joint involvements which can affect their outcome.
• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (1)

Atrium Medical Center

Heerlen, Netherlands

Location

Results Point of Contact

• Title: Doug McGurty
• Organization: Stryker EU Operations B.V. Herikerbergweg 110 1101 CM Amsterdam The Netherlands

doug.mcgurty@stryker.com

+44 (0) 1635 500690

Study Officials

• Ide C. Heyligers, MD

  Atrium Medical Center, Heerlen, The Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 17, 2015
• Study Start: October 1, 2010
• Primary Completion: January 12, 2016
• Study Completion: January 12, 2016
• Last Updated: February 22, 2024
• Results First Posted: March 6, 2019

Record last verified: 2024-02

Locations

NL (1)