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Completed

NCT Number: NCT02635581

A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™

The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.

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Key information

Conditions

Primary Total Hip Replacement

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna, Cona, Ferrara, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI< 40 kg/m2
  • Indication suitable to the implantation of Delta TT acetabular cup (First implant)
  • Idiopathic osteoarthritis
  • Avascular necrosis
  • Post-traumatic arthritis
  • Presence of sufficient periacetabular bone stock
  • Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups
  • Written informed consent

Exclusion criteria

  • Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
  • Patients aged 76 or older
  • Haemophilic disease
  • Femur neck fracture
  • Insulin Dependent Diabetes Mellitus (IDDM)
  • Severe kidney failure (grade 4)
  • Not responder Hypo- or Hyperthyroidism
  • Paget's disease
  • Tumours
  • Active or suspicious infections
  • Neurosensory deficits or neuromuscular diseases
  • Severe and impairing vascular diseases
  • Known incompatibility or allergy to products materials
  • Woman with pregnancy or childbearing capacity or breast-feeding
  • Subjects already enrolled in other clinical trials

Treatment and study plan

Delta TT acetabular cup

Device

Primary outcomes

  1. The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan

    Time frame: From baseline to 5 year Follow-up

Secondary outcomes

  1. Harris Hip Score (HHS)

    Time frame: From baseline to 5 year Follow-up

  2. SF-36 score

    Time frame: From baseline to 5 year Follow-up

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Dec 21, 2015
Registry last updated
Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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