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TerminatedNCT01422564MOMUpdated May 15, 2015

Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

A Phase 4 interventional study of Metal on Metal Hip System and Highly Cross Linked Polyethylene cup System in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Nova Scotia Health Authority. Terminated. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-05-15.

Sponsored by Nova Scotia Health Authority · Phase 4, Interventional, and Treatment

Why this study was terminated
Components were recalled by Depuy
Phase
Phase 4
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.

02

Conditions studied

  • Osteoarthritis
  • Avascular Necrosis
  • Rheumatoid Arthritis
  • Congenital Dysplasia of the Hip
  • Ankylosing Spondylitis
  • Post-traumatic; Arthrosis
  • Injury of Hip and Thigh
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 41 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and non-pregnant female subjects 65 years of age or older
  • Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
  • Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
  • Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.

Exclusion criteria

Exclusion Criteria:

  • Subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis.
  • Subjects with gross obesity, >45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
  • Subjects with active infections.
  • Subjects with malignancy in the area of the involved hip joint.
  • Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
  • Subjects with a diagnosis of Fibromyalgia
  • Female subjects who are pregnant or may be pregnant.
  • Subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.
  • Subjects who have a known sensitivity to device materials.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    Metal on Metal

    Metal on Metal articulation system

    Device: Metal on Metal Hip System

  • Active comparator
    HCLPC

    THA using Highly Cross Linked Polyethylene cup System

    Device: Highly Cross Linked Polyethylene cup System

Interventions

  • DeviceMetal on Metal Hip System

    Total hip arthroplasty with a metal on metal component system

    Also known as: Depuy ASR

  • DeviceHighly Cross Linked Polyethylene cup System

    Total hip arthroplasty with Highly Cross Linked Polyethylene cup System

    Also known as: Depuy Pinnacle Cup and Marathon liner

06

What researchers measure

Primary outcomes

  1. Revision Rate

    Time frame: 4 years

Secondary outcomes

  1. Wear and osteolysis

    Time frame: 5-15 years

  2. Harris Hip Score

    Time frame: immediate post-op, 6 months, 1 year, 2 years, 4 years

  3. Dislocation Rate

    Time frame: 4 years

  4. Complication Rate

    All complications

    Time frame: 4 years

  5. Gait Analysis

    Using the Walkabout portable gait monitor

    Time frame: 6 months and 1 year post-op

  6. Metal Ions

    Time frame: 4 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01422564
Lead sponsor
Nova Scotia Health Authority
Collaborators
University Health Network, Toronto
Responsible party
Sponsor
First posted
Aug 24, 2011
Start date
Jan 2007
Primary completion
Dec 2010
Completion
Dec 2010
Last update
May 15, 2015

Study contacts

Ross K Leighton, MD
principal investigator · Nova Scotia Health Authority

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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