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NCT Number: NCT05459948

The Medacta GMK SpheriKA Post-Marketing Surveillance Study

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

Recruiting

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Key information

Conditions

Arthropathy Joint Diseases Knee Replacement Musculoskeletal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de l'Arthrose, Mérignac, France

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About this study

The aim of the current study is to collect clinical and radiological data to monitor the performances of the "GMK® SpheriKA" Knee Prosthesis implanted via the kinematic alignment technique.

Who can participate

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

Inclusion criteria

  • Patients willing to sign the informed consent.
  • Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
  • Patients 18 - 80 years of age at the time of surgery.
  • Patients requiring a primary total knee replacement (on label use).
  • Patients with intact collateral ligaments.

Exclusion criteria

  • Patients with inflammatory arthritis.
  • Morbidly obese patients, with a body mass index (BMI) > 40.
  • Patients with a history of total or unicompartmental reconstruction of the affected joint.
  • Patients that have had a high tibial osteotomy or femoral osteotomy.
  • Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
  • Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
  • Patients that are immunologically compromised or receiving chronic steroids (> 30 days).
  • Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis.
  • Patients with an active or suspected latent infection in or surrounding the knee joint.
  • Pregnant or breastfeeding women.

Treatment and study plan

GMK SpheriKA

Device

The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique

Primary outcomes

  1. Primary objective will be evaluated with the Forgotten Joint score (FJS).

    Time frame: 6 weeks, from 1 to 10 years annually

    study the efficacy of the treatment to make the patient forget the presence of the artificial joint in everyday life.

    The Forgotten Joint Score assessment 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

Secondary outcomes

  1. patient-reported outcomes 1

    Time frame: 6 weeks, from 1 to 10 years annually

    Oxford Knee Score: The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks

  2. Satisfaction and Expectations questionaires

    Time frame: 6 weeks, from 1 to 10 years annually

    Satisfaction and Expectations questionaires

    Patient reported satisfaction and expectations answering some questions of the "satisfaction and expectation knee society score", the goal is to collect all final answers and have an overview on how the patient feels.

    "Patient Expectations" is a three-question fifteen-point scale that is collected pre-operatively and post-operatively.

    "Patient Satisfaction" is a five-question 40-point scale that is collected preoperatively and at each follow-up visit.

  3. Radiological outcomes

    Time frame: pre-op, 6weeks, 1, 2,5,10 years

    Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis

  4. Adverse events

    Time frame: during surgical operation, 6weeks, 1,2,5,10 years

    Adverse events (type of complications, dependent or not from the device etc)

  5. Limb alignment

    Time frame: on preoperative and 6-week x-rays

    Limb alignment will be measured: mMPTA (°), mLDFA (°) and joint line (HKA) will be recorded.

    HKA = Hip-Knee-ankle angle measured in degrees mMPTA = mechanical medial proximal tibial angle measured in degrees mLDFA = mechanical lateral distal femoral angle measured in degrees

  6. Lateral uncoverage of the anterior femoral resection

    Time frame: During Surgical Operation

    Measurement of the lateral uncoverage of the anterior femoral resection measured in mm

Study contacts

Contact information is provided by the study sponsor or research team.

Arianna Girardi

CONTACT

[email protected]

+41 91 696 60 60

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study

Important dates

Study start
2022
Primary completion
2035
Study completion
2035
First posted
Jul 15, 2022
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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