Clinical Trials Logo
  1. Home
  2. Osteoarthritis, Hip
  3. NCT03147131
  4. Details
NCT03147131 Clinical Trial

Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem

Osteoarthritis, Hip Clinical Trial

Official title:
Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem: Five-Year Results Of A Prospective, Randomized DEXA-Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03147131
Other study ID # D.3067-244/10
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 19, 2016
Last updated May 14, 2017
Start date August 1, 2010
Est. completion date July 2017

Study information
Verified date May 2017
Source University Hospital Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the proximal femur after implantation of the Fitmore compared to the CLS stem.

Description:

After power analysis, 140 consecutive patients were prospectively included in the randomisation protocol receiving either a Fitmore short or a CLS straight stem. The short stem was assigned in 57 (37% females) cases and the straight stem in 83 (38% females) hips. Periprosthetic bone mineral density was measured before surgery, 7 days, 3, 12 and 60 months postoperatively, using dual energy x-ray absorptiometry (DEXA). The results of the first postoperative measurement served as the baseline value. Because of the different length of the two prostheses we used adapted Gruen zones to divide the periprosthetic bone in seven regions of interest (ROI) with equal length in the proximal zones 1,2,6 and 7, only the regions 3 and 5 featured different sizes. Clinical results were recorded using the WOMAC and the Harris hip score (HHS).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 126
Est. completion date July 2017
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Primary or secondary osteoarthritis of the hip

- written informed consent

- indication for cementless total hip arthroplasty

Exclusion Criteria:

- previous surgery in the same hip

- femoral fracture

- metabolic bone disease

- drugs affecting bone quality

- contralateral THA within the study period

- infectious disease or bony tumor

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Total Hip Arthroplasty
Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Ulm

References & Publications (1)

Freitag T, Hein MA, Wernerus D, Reichel H, Bieger R. Bone remodelling after femoral short stem implantation in total hip arthroplasty: 1-year results from a randomized DEXA study. Arch Orthop Trauma Surg. 2016 Jan;136(1):125-30. doi: 10.1007/s00402-015-2370-z. Epub 2015 Nov 27. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Stem specific stress shielding of a short compared to a straight hip stem Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem Five years postoperatively
Secondary Clinical Outcome after short compared to straight stem THA Clinical outcome measured with the Harris Hip Score and the WOMAC Five years postoperatively
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
Terminated NCT00588861 - Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement 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