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Clinical Trials/NL-OMON55672
NL-OMON55672
Recruiting
Not Applicable

A prospective study to evaluate long-term clinical outcomes of the GTS cementless femoral stem - H36 GTS international

Zimmer Biomet0 sites23 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Joint wear
Sponsor
Zimmer Biomet
Enrollment
23
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Male and non\-pregnant females : \>\= 18 years and \<\= 70 years
  • 2\. Patients requiring primary THR, suitable for the use of the GTS stem.
  • 3\. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis.
  • 4\. The individual is physically and mentally willing and able to comply with
  • postoperative functional evaluation and able to participate in an appropriate
  • rehabilitation schedule.
  • 5\. ASA classification score I\-III.
  • 6\. Patients who signed the Ethics Committee approved specific Informed Consent
  • Form prior to surgery.
  • 7\. Surgical technique is planned to be Anterior Supine Intramuscular (ASI), or

Exclusion Criteria

  • 1\. Patients who had a THA on contralateral side more than 6 months ago and the
  • rehabilitation period outcome is considered unsatisfactory or not good.
  • (Patients with contra\-lateral THA \>6 months ago with good outcome (Harris Hip
  • Score \>85\) can be included in the study).
  • 2\. Patients who had a THA on contralateral side less than 6 months ago.
  • 3\. Patients with a major surgical procedure during the 12 weeks before the
  • study\-related

Outcomes

Primary Outcomes

Not specified

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