NCT03270982

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
116mo left

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Apr 2016Dec 2035

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
18.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

19.7 years

First QC Date

August 30, 2017

Last Update Submit

December 16, 2025

Conditions

Degenerative DiseaseOncologyRevision SurgeryTraumaRheumatoid Arthritis

Keywords

Non Inflammatory Degenerative Joint DiseaseRheumatoid ArthritisRevision where other devices have failedCorrection of functional deformityOncology ApplicationsTreatment of acute or Chronic fractures

Outcome Measures

Primary Outcomes (1)

  • Implant survivorship assessed according to the implant revisions

    Implant survivorship assessed counting the number of implant revisions

    10 years

Secondary Outcomes (5)

  • Clinical patient outcome measure: QuickDASH

    Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative

  • Clinical patient outcome measure: Constant-Murley Score

    Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative

  • Clinical patient outcome measure: Liverpool Elbow Score

    Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative

  • Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)

    6 months, 1 year, 3 years and 5 years post-operative

  • Safety is assessed according to the number of complications

    10 years

Study Arms (1)

Comprehensive SRS Replacement

Comprehensive SRS Device

Device: Comprehensive SRS Replacement

Interventions

Comprehensive SRS ReplacementDEVICE

This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.

Comprehensive SRS Replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will come from Primary Care Clinics

You may qualify if:

  • 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

You may not qualify if:

  • Sepsis ( active)
  • Infection ( active)
  • Osteomyelitis (active)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H-1796, Canada

Location

Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen

Copenhagen, Denmark

Location

Royal Gwent Hospital

Newport, Wales, NP20 2UB, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

NeoplasmsWounds and InjuriesArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Emilie Rohmer

    Clinical Operations Director Zimmer Biomet EMEA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

April 1, 2016

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

GB(2)CA(1)DK(1)