NCT02756702

Brief Summary

Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation For this PMCF only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

April 27, 2016

Last Update Submit

June 23, 2023

Conditions

Degenerative OsteoarthritisRheumatoid ArthritisPost-traumatic; ArthrosisOther Instability, KneeStiffness of Knee, Not Elsewhere ClassifiedDeformity of Knee Joint

Keywords

TKATKRAll-Polyposterior stabilized

Outcome Measures

Primary Outcomes (1)

  • Revision Rate

    The objective of the study is to collect clinical midterm outcome information on the product under investigation when used in routine clinical practice.

    5 years

Secondary Outcomes (5)

  • Complication/Adverse Event rate

    5 years

  • KOOS (Knee Osteoarthritis Outcome Score)

    5 years

  • KSS (Knee Society Score)

    5 years

  • SF-12® Health Survey (SF-12)

    5 years

  • Change of anterior knee pain over follow-up period

    5 years

Study Arms (1)

All-Poly

All-polyethylene tibia VEGA System® PS - A posterior stabilized total knee arthroplasty (TKA) system using solely all-polyethylene tibia components

Device: All-Poly

Interventions

All-PolyDEVICE

Implantation of the VEGA PS using all-polyethylene tibia components

Also known as: Total Knee Replacement
All-Poly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
  • degenerative osteoarthritis;
  • rheumatoid arthritis;
  • posttraumatic arthritis;
  • symptomatic knee instability;
  • knee stiffness or deformation of the knee joint;
  • Age ≥ 18 years;
  • Patient signed informed consent

You may not qualify if:

  • Age younger than 18 years
  • Any prior joint replacement at the index knee
  • Unable or unwilling to return for postoperative follow-up
  • Patient did not sign informed consent
  • Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
  • Acute or chronic infections near the joint, or systemic infections
  • Secondary diseases that could influence joint implant functionality
  • Systemic diseases and metabolic disorders
  • Severe osteoporosis or osteomalacia
  • Severely damaged bone structures that could prevent stable implantation of implant components
  • Bone tumors in the region of implant fixation
  • Bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint
  • Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity
  • Dependency on pharmaceutical drugs, drug abuse, or alcoholism
  • Fever, infection or inflammation (systemic or local)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MEDBALTIC GmbH c/o Mare Klinikum

Kiel, 24119, Germany

Location

MeSH Terms

Conditions

Joint DiseasesArthritis, RheumatoidOsteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Ludger Gerdesmeyer, Professor

    orthopedics

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2016

First Posted

April 29, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

October 6, 2022

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)