Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00588861
Other study ID # 101-U-011
Secondary ID
Status Terminated
Phase N/A
First received December 19, 2007
Last updated January 26, 2017
Start date September 2002
Est. completion date May 2010

Study information

Verified date January 2012
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.


Description:

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.


Recruitment information / eligibility

Status Terminated
Enrollment 400
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis

- Rheumatoid arthritis

- Correction of functional deformity

- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Exclusion Criteria:

- Infection, sepsis, and osteomyelitis

Study Design


Intervention

Device:
Answer® hip stem
Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
Answer® hip stem
Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Locations

Country Name City State
United States Biomet Orthopedics, LLC Warsaw Indiana

Sponsors (1)

Lead Sponsor Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Harris Hip Score The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor." 10 Years Post-Operative
Secondary Harris Hip Score Pain Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled." Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05773261 - Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups N/A
Recruiting NCT05223777 - KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA) N/A
Recruiting NCT04731077 - Avenir Complete Post-Market Clinical Follow-Up Study N/A
Not yet recruiting NCT04448106 - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis Phase 2
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT06162195 - The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement N/A
Withdrawn NCT02743208 - Evaluation of a Short Femoral Stem in Total Hip Arthroplasty N/A
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Active, not recruiting NCT02229279 - Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures N/A
Active, not recruiting NCT02851992 - A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem N/A
Completed NCT01700933 - Dose-response: Exercise Therapy on Hip Osteoarthritis N/A
Completed NCT01618708 - A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip N/A
Completed NCT01214954 - Early Rehabilitation After Total Hip Replacement N/A
Active, not recruiting NCT00294424 - Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements N/A
Withdrawn NCT05054595 - Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention N/A
Terminated NCT00973141 - A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain Phase 2
Recruiting NCT05014113 - H-28 DELTA ST-C and Minima Retrospective Study.
Completed NCT01066936 - Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Recruiting NCT06185036 - Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
Recruiting NCT05530551 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA N/A