NCT02199600

Brief Summary

This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
2 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 Progress80%
Oct 2012Oct 2029

Study Start

First participant enrolled

October 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

17 years

First QC Date

July 7, 2014

Last Update Submit

December 11, 2024

Conditions

ArthritisTraumatic ArthritisRheumatoid ArthritisPoly-arthritisAvascular Necrosis

Outcome Measures

Primary Outcomes (1)

  • Assessment of the clinical outcome following total knee replacement using the Knee Society Score.

    6 months

Secondary Outcomes (5)

  • The OXFORD score as a measure of implant functionality.

    pre-op, 6 months and annually for 10 years

  • Assessment of implant survivorship as a measure of safety and tolerability.

    6 weeks, 6 months, 3, 5, 7 and 10 years.

  • Radiographic analysis

    pre-op, 6 months, 3, 5,7 and 10 years.

  • The EuroQol score as a measure of patient' quality of life.

    pre-op, 6 months, 3, 5,7 and 10 years

  • Assessment of the clinical outcome following total knee replacement using the Knee Society Score

    pre-op, at 6 months, at 3, 5, 7 and 10 years.

Study Arms (1)

GMK Sphere Knee Replacement

OTHER

Patients who comply with the protocol and received GMK Sphere component.

Device: GMK Sphere Knee Replacement

Interventions

GMK Sphere Knee ReplacementDEVICE
GMK Sphere Knee Replacement

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
  • Patients must be between the age of 18 and 80 at the time of consent
  • Listed for total knee replacement surgery.
  • Patients who are willing to give informed written consent

You may not qualify if:

  • Progressive local or systemic infection
  • Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
  • Severe instability secondary to advance destruction of condylar structures or loss of integrity of the medial or lateral ligament
  • Any patient who cannot or will not provide informed consent for participation in the study
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
  • Patient whose BMI exceeds 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Royal London Hospital

Whitechapel, London, E11BB, United Kingdom

Location

Royal National Orthopaedic Hospital NHS Trust

Stanmore, Middlesex, HA74LP, United Kingdom

Location

The Elective Orthopaedic Centre (EOC)

Epsom, Surrey, KT18 7EG, United Kingdom

Location

MeSH Terms

Conditions

ArthritisArthritis, RheumatoidOsteonecrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 24, 2014

Study Start

October 1, 2012

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations

GB(3)BE(1)