Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component

NCT01285843 | Completed Results

• 1 other identifier: P01.004.14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.

Conditions

Osteoarthritis; Arthritis; Avascular Necrosis; Fracture of the Femoral Neck or Head; Congenital Hip Dysplasia

Outcome Measures

Primary Outcomes (1)

• Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.

  0-12 months

Secondary Outcomes (3)

• Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score

  6 weeks, 6 months, 1 year

• Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.

  6 months, 1 year

• Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.

  6 months, 1 year

Study Arms (2)

Quadra Group

ACTIVE COMPARATOR

Procedure: Anterior Minimally Invasive Approach (AMIS)

AMIStem Group

ACTIVE COMPARATOR

Procedure: Anterior Minimally Invasive Approach (AMIS)

Interventions

Anterior Minimally Invasive Approach (AMIS) PROCEDURE

AMIStem Group; Quadra Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
• Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)).
• Patients must be willing to comply with the pre and post-operative evaluation schedule.
• Patients with only one lower limb arthroplasty

You may not qualify if:

• Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism
• Patients with osteoporosis (pre-op T-score \< -2,5)
• Patients with significant comorbidities
• Patients with both hip and knee arthroplasty
• Patients with restricted mobility
• Patient with severe hip contracture
• Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

St. Elisabeth Dillingen

Dillingen an der Donau, Bavaria, 89407, Germany

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Osteonecrosis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Ing. Elisa Bonacina, Clinical Data Manager
• Organization: Medacta International

bonacina@medacta.ch

+41 91 696 60 60

Study Officials

• Martin Nolde, Dr. Med.

  DGOOC; BVO; BVASK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 28, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 9, 2025
• Results First Posted: September 15, 2014

Record last verified: 2025-09

Locations

DE (1)