Clinical trial NCT03270982: Comprehensive Segmental Revision System
Official title: Comprehensive Segmental Revision System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Disease
Oncology
Revision Surgery
Trauma
Rheumatoid Arthritis
Keywords: Non Inflammatory Degenerative Joint Disease
Rheumatoid Arthritis
Revision where other devices have failed
Correction of functional deformity
Oncology Applications
Treatment of acute or Chronic fractures
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-09-01
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will come from Primary Care Clinics

Brief summary: Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.

Detailed description: The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance.

The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).

Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases.

The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least ten (10) years from the time of surgery.

Eligibility criteria: Inclusion Criteria:

* Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
* Rheumatoid arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity
* Oncology applications including bone loss due to tumour resection

Exclusion Criteria:

* Sepsis ( active)
* Infection ( active)
* Osteomyelitis (active)

Primary outcomes:
measure: Implant survivorship assessed according to the implant revisions
timeFrame: 10 years
Secondary outcomes:
measure: Clinical patient outcome measure: QuickDASH
timeFrame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
measure: Clinical patient outcome measure: Constant-Murley Score
timeFrame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
measure: Clinical patient outcome measure: Liverpool Elbow Score
timeFrame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
measure: Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)
timeFrame: 6 months, 1 year, 3 years and 5 years post-operative
measure: Safety is assessed according to the number of complications
timeFrame: 10 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Copenhagen
country: Denmark
facility: Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
state: Wales
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
Study officials:
affiliation: Clinical Operations Director Zimmer Biomet EMEA
name: Hassan Achakri
role: STUDY_DIRECTOR
References: