Non-Interventional, Multicenter Bicontact® E PMCF Study

Prospective observational (non-interventional) cohort study, multi-centric in 5 study Centers in Japan to collect short term clinical and radiological results of the cementless Bicontact® E stem in a standard patient population used in routine clinical practice

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Key information

Conditions

Degenerative Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Femoral Fractures Femoral Head Necrosis Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Immune System Diseases Joint Diseases Leg Injuries Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Funabashi Orthopedic Hospital, Funabashi, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Indication for Bicontact E prosthesis THA
Patients ≥ 18 years
Patient not pregnant
Written informed consent

Exclusion criteria

Patients receiving a bipolar implantation

Treatment and study plan

Primary outcomes

Clinical Results

Time frame: 1 year

Hip Score of the Japanese Orthopaedic Association (JOA): three categories-movement, mental, and pain-each comprising 7 items, for a total of 21 items to be used as evaluation criteria for hip-joint function

Secondary outcomes

Thigh Pain

Time frame: 1 year

Pain as measured with the Visual Analog Scale (VAS): Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal analog scale of 100 mm length. It is anchored by two verbal descriptors, one for each symptom extreme [no pain - worst imaginable pain].
X-Ray evaluation

Time frame: 1 year

Radiological results (osteointegration, migration)
(Serious) Adverse Events

Time frame: 1 year

Complications: Adverse Events (AE) / Serious Adverse Events (SAE)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Feb 22, 2018
Registry last updated: Sep 19, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed