Clinical trial NCT04255966: Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Official title: Prospective, Multi-centric, Comparative, Long-term Clinical Follow-Up Study for the Evidence of Safety and Performance Indicators of the Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteolysis
Arthroplasty Complications
Instability of Prosthetic Joint
Degenerative Osteoarthritis
Rheumatic Arthritis
Fractures, Hip
Femoral Head Avascular Necrosis
Prosthesis Failure
Keywords: Revision of the acetabular implant
orthopaedic surgery
osteolysis
wear particles
cup loosening
malpositioned cup
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having acute disorders of the hip, requiring primary or revision surgery, which cannot be treated by other therapies:

* Degenerative osteoarthritis
* Rheumatic arthritis
* Fractures of the joint
* Femoral head necrosis
* Revision surgery where a sufficient intraoperative press-fit can be achieved

Brief summary: The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.


Eligibility criteria: Inclusion Criteria

* Indication for the cementless Plasmafit® Revision Structan® Hip Endoprosthesis Cup (primary and revision cases, with bone conditions typically demanding a press-fit revision cup)
* Written informed consent
* Cases where a press-fit cup fixation is possible

Exclusion Criteria

* Patients \< 18 years
* Pregnant patients
* Patients not able to comply with the study demands, i.e. follow-up visits (mentally or physically)
* Patient has an infection in the hip joint region

Primary outcomes:
measure: Harris Hip Score (Functional results of the operated hip) over time
timeFrame: up to five years postoperatively
Secondary outcomes:
measure: Survival of the implant
timeFrame: up to five years postoperatively
measure: Quality of Life over time
timeFrame: up to five years postoperatively
measure: Radiological Assessment: Osseointegration of the cup over time
timeFrame: at 3 months, 24 months, 5 years follow-up
measure: Radiological assessment: Radiographic loosening of the cup over time
timeFrame: at 3 months, 24 months, 5 years follow-up
measure: Technical problems during surgery
timeFrame: Intraoperative
measure: Impingement
timeFrame: Intraoperative
measure: General handling of instruments / containers
timeFrame: Intraoperative
measure: Complications
timeFrame: up to 5 years postoperatively
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Orthopädische Klinik König-Ludwig-Haus
state: Bayern
city: Braunschweig
country: Germany
facility: Herzogin Elisabeth Hospital
state: Niedersachse
city: Bonn
country: Germany
facility: Gemeinschaftskrankenhaus Bonn
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
Study officials:
affiliation: University Hospital, Saarland
name: Stefan Landgraeber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: