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Active, Not Recruiting

NCT Number: NCT05003414

The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Poly-arthritis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Traumatic Arthritis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Saint Vincent de Paul, Bourgoin, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 condralar structures or loss of integrity of the medial or lateral ligament
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
  • Patient whose BMI exceeds 40
  • Any case not described in the inclusion criteria

Treatment and study plan

GMK Sphere cementless Knee Replacement

Device

Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement

Primary outcomes

  1. Survival rate

    Time frame: 10 years

    Kaplan Meier method

Secondary outcomes

  1. Clinical outcome: Knee Society score

    Time frame: Preop and 1, 2, 5, 10 years postop

    Knee Society Score (KSS): evaluates pain, in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability.

  2. Patient-reported outcome: Forgotten Joint Score

    Time frame: 1, 2, 5, 10 years postop

    Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment.It consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities

  3. Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence

    Time frame: Immediately postop + 1, 2, 5, 10 years postop

    Presence of radiolucencies, migration, loosening, subsidence

  4. Intraoperative and postoperative Adverse events

    Time frame: Intraop + Immediately postop + 1, 2, 5, 10 years postop

    Intraoperative and postoperative adverse events

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis

Important dates

Study start
2020
Primary completion
2030
Study completion
2032
First posted
Aug 12, 2021
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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