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

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Procedure: Total Hip Arthroplasty

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Fitmore short stem; Intervention: Total hip arthroplasty with an uncemented femoral short stem, the Fitmore short stem (Zimmer, Warsaw, USA). Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA). Device: Fitmore Short Stem	Procedure: Total Hip Arthroplasty; Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.
ACTIVE_COMPARATOR: CLS straight stem; Intervention: Total hip arthroplasty with an uncemented femoral straight stem, the CLS short stem (Zimmer, Warsaw, USA).Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA). Device: CLS Straight Stem	Procedure: Total Hip Arthroplasty; Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome after short compared to straight stem THA	Clinical outcome measured with the Harris Hip Score and the WOMAC	Five years postoperatively

Collaborators and Investigators

• Sponsor: University Hospital Ulm
• Investigators: Principal Investigator: Ralf Bieger, PD Dr., University Hospital Ulm - Department of Orthopedic Surgery

Publications and helpful links

General Publications

• 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.
• Meyer JS, Freitag T, Reichel H, Bieger R. Mid-term gender-specific differences in periprosthetic bone remodelling after implantation of a curved bone-preserving hip stem. Orthop Traumatol Surg Res. 2020 Dec;106(8):1495-1500. doi: 10.1016/j.otsr.2020.04.023. Epub 2020 Oct 31.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2010
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; DEXA; Short Stem
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: D.3067-244/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.