Changes of Bone Mineral Density in Total Hip Arthroplasty

NCT ID: NCT04962854

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2021-04-01

Brief Summary

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.

Detailed Description

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.

Conditions

Bone Mineral Density

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Monoblock Cup

53 patients received a monoblock cup (RM Pressfit vitamys®)

No interventions assigned to this group

Modular Cup

64 patients received a modular cup (ANA.NOVA® Implantec)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Vincent Hospital, Vienna

OTHER

Sponsor Role: lead

Responsible Party

Michael Tiefenboeck

Dr. med. univ

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

DEXA THA

Identifier Type: -

Identifier Source: org_study_id