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Procedure

Total Hip Replacement Surgery Survivorship Study

N/A
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is a male or non-pregnant female age 21 years or older at the time of study device implantation
Patient is a candidate for primary cementless total hip replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-op
Awards & highlights

Study Summary

This trial will compare the two-year survivorship of a currently-used femoral stem when implanted using two different surgical approaches.

Who is the study for?
This trial is for adults over 21 with non-inflammatory degenerative joint disease who need a primary cementless total hip replacement. They must be able to follow the study's procedures and attend follow-up visits. People with a BMI over 40, those needing revision surgery, with material sensitivities, active infections, or immunosuppression cannot participate.Check my eligibility
What is being tested?
The study tests the Bone Preservation Tri-Lock femoral stem in total hip replacements using two surgical methods: direct anterior and anterolateral approaches. It aims to compare implant survival rates, radiographic outcomes, and patient functionality after two years.See study design
What are the potential side effects?
While not specified here, typical side effects of total hip arthroplasty may include pain at the site of surgery, swelling around the hip area, bruising or bleeding post-operation, risk of infection and possible dislocation or loosening of the new joint over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 or older and not pregnant.
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I am eligible for a hip replacement without cement.
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I have been diagnosed with a non-inflammatory joint condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survivorship of Bone Preservation Tri-Lock femoral stem
Secondary outcome measures
TUG (timed up and go) Score

Trial Design

2Treatment groups
Active Control
Group I: Total Hip Arthroplasty performed via direct anterior approachActive Control1 Intervention
Group II: Total Hip Arthroplasty using anterolateral approachActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,578 Total Patients Enrolled

Media Library

Total Hip Arthroplasty (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01566916 — N/A
Total Hip Replacement Research Study Groups: Total Hip Arthroplasty performed via direct anterior approach, Total Hip Arthroplasty using anterolateral approach
Total Hip Replacement Clinical Trial 2023: Total Hip Arthroplasty Highlights & Side Effects. Trial Name: NCT01566916 — N/A
Total Hip Arthroplasty (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01566916 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
2024. "Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01566916.
~233 spots leftby Apr 2025
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