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Completed

NCT Number: NCT04962854

Changes of Bone Mineral Density in Total Hip Arthroplasty

The study was performed as a prospective, single center study at the Department of Orthopedics, Sacred Heart of Jesus Hospital Vienna, Austria. 117 patients were enrolled in a from January 2016 to May 2017. 53 patients received an isoelastic monoblock cup (RM Pressfit vitamys® Mathys) and 64 patients received a metal- backed modular cup (ANA.NOVA® ImplanTec). Dual-energy x-ray absorptiometry scans according to DeLee and Charnley Zones were performed at time points 0, 3, 6, 12, and 24 months after surgery. The aim of thise study was to compare changes in BMD between an isoelastic monoblock cup and a titanium modular cup. We hypothesized that the more elastic monoblock cup performs better than the more rigid modular cup with regard to changes in BMD.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The study was performed as a prospective, single center study at the Department of Orthopedics, Sacred Heart of Jesus Hospital Vienna, Austria.

Inclusion criteria

were as follows: any patient aged from 18 years onwards undergoing primary cementless THA for degenerative joint disease, including osteoarthritis, post-traumatic arthritis, congenital hip dysplasia and avascular necrosis. Excluded were all patients with malignant diseases and pregnant women, additionally, patients were excluded if severe complications such as fracture or revision surgery occurred during the study period.

Patients were enrolled from January 2016 to May 2017, a total of 117 patients were included. All patients underwent uncemented THA, patients either received a monoblock cup (RM Pressfit vitamys®; Mathys Ltd. Bettlach, Switzerland), or a titanium shell (ANA.NOVA® Implantec, Mödling, Austria). DEXA measurements according to the DeLee and Charnley Zones were performed postoperatively, 3, 6, 12 and 24 months after primary hip arthroplasty. Bone mineral density (BMD) was measured by using the bone densiometer (Lunar, Prodigy, GE Medical Sytsems). A special legholder was used to fix the leg to ensure the same rotation and avoid measurement errors. DEXA measurements were performed and analyzed by two trained authors. Statistical analysis focused on differences in BMD between monoblock cup and modular cup after 3, 6, 12 and 24 months as well as changes in BMD in relation to cup inclination. In order to gain valid results, the nonparametric Wilcoxon rank-sum test was used. We used t-Test to evaluate differences to the baseline. A probability value of p ≤0.05 was considered as statistically significant. Data was analyzed using Microsoft Excel® and SPSS® (version 26.0, SPSS Inc., Chicago, IL, USA) representing standard statistical software. We hypothesized that the more elastic monoblock cup performs better than the more rigid modular cup with regard to changes in BMD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • any patient aged from 18 years onwards undergoing primary cementless THA for degenerative joint disease, including osteoarthritis, post-traumatic arthritis, congenital hip dysplasia and avascular necrosis.

Exclusion criteria

  • patients with malignant diseases and pregnant women, additionally, patients were excluded if severe complications such as fracture or revision surgery occurred during the study period.

Treatment and study plan

Primary outcomes

  1. Dexa meassurments

    Time frame: 24 Months

    Changes in BMD according to DeLee and Charnley Zones

Sponsors and collaborators

Lead sponsor

St. Vincent Hospital, Vienna

Other

Registry information

Official study title

Changes of Bone Mineral Density in Total Hip Arthroplasty - A Prospective Comparison of Isoelastic and Metal-backed Cup Designs

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jul 15, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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