Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

NCT01496300 | Completed Phase 4

• 1 other identifier: AAG-G-H-1103
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This study was initiated to investigate the impact of the computer based image free navigation on the precision of the cup implantation. The implantation of the acetabular component (cup) is known to be a critical step in hip endoprosthetics. The cup position influences significantly the function, the absence of pain and the longevity of the artificial hip joint. The image free navigation system OrthoPilot is used to control the positioning of the cup during surgery.

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Femur Head Necrosis

Keywords

Navigation OrthoPilot Hip TEP THA

Outcome Measures

Primary Outcomes (1)

• Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation

  The ratio of implantations within the intraoperatively adjusted safe zone of Lewinnek (target anteversion +/-10°, target inclination +/-10°), proved by a CT-scan control measurement.

  3 months

Secondary Outcomes (1)

• Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.

  3 months

Study Arms (2)

Manual

SHAM COMPARATOR

Manual Implantation of THA

Procedure: Manual Intervention

Navigated

EXPERIMENTAL

Navigated Implantation of THA

Procedure: Navigated Intervention

Interventions

Manual Intervention PROCEDURE

Implantation of acetabular component without the use of the navigation system information

Also known as: Conventional THA

Manual

Navigated Intervention PROCEDURE

Navigated implantation of acetabular component using OrthoPilot image free navigation system

Also known as: Computer assisted orthopedic surgery

Navigated

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for primary cementless total hip endoprosthesis implantation with Bicontact stem and Plasmacup
• Diagnoses: primary or secondary coxarthrosis, rheumatoid arthritis, femoral head necrosis
• Age ≥ 50 Years
• ASA score \<4
• Patient signed the informed consent

You may not qualify if:

• Excessive damage to the hip joint (e.g. dysplasia)
• Severe deformities of the pelvis, femoral bone or knee
• Unfeasibility of landmark palpation (e.g. due to adiposity)
• Acute or chronic infection
• Pregnancy
• Patients not available for follow-up-examination at the center
• Patients exceeding 10 mSv effective radiation dose because of previous scientific or clinical exposition during the past 10 years

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Lukas-Krankenhaus

Bünde, 32257, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hartmuth Kiefer, Prof. Dr.

  Lukas Krankenhaus Bünde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 21, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

DE (1)