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Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

Sponsor
Medacta USA (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02501733
Collaborator
(none)
260
Enrollment
4
Locations
1
Arm
102
Duration (Months)
65
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num: 20141994) and randomized to the Sphere arm, will have their data utilized for this study.

Condition or Disease Intervention/Treatment Phase
  • Device: Medacta GMK Sphere® Medial Knee Prosthesis
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
260 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Medacta GMK Sphere® Medial Pivot, Cruciate Substituting Multicenter, Post-Market Outcomes Study
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Medacta GMK Sphere® Knee Prosthesis

All subjects enrolled will receive the Medacta GMK Sphere® Medial Knee Prosthesis

Device: Medacta GMK Sphere® Medial Knee Prosthesis
There is no consensus within the Arthroplasty community as to whether a traditional post and cam-style Posterior Stabilized total knee device is superior to a medial-pivot, more congruent device. However, the majority of surgeons seem to prefer the former, though there is a minority that uses the latter device with great success. To date, there have been few prospective trials directly comparing these devices, and none with the latest generation of Total Knee Arthroplasty implants. Almost all such studies have been retrospective and/or utilizing older generation devices.
Other Names:
  • Total Knee Arthroplasty
  • Total Knee Prosthesis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively. [Baseline, 2 and 5 year time points]

      Knee function-patients ability to forget the artificial joint in everyday life.

    Secondary Outcome Measures

    1. Total Knee Society Score (KSS) [Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years.]

      Total Knee Society score questionnaire to assess pain and function

    2. Krackow Activity Scale (KAS) [Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years]

      The Krackow Activity Scale (KAS) lower extremity activity scale.

    3. Radiographic Analysis [Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years]

    4. AP long standing X-ray [Pre-operative and 6 weeks]

      Determine degree of Varus or Valgus

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    • Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery.

    • Patients requiring a primary total knee replacement.

    • Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).

    • Patients with intact collateral ligaments.

    Exclusion Criteria:

    • Patients with inflammatory arthritis.

    • Patients that are morbidly obese, 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 bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.

    • Patients with knee fusion to the affected joint.

    • Patients with an active or suspected latent infection in or about the knee joint.

    • Patients that are prisoners.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Norhtwestern University Chicago Illinois United States 60611
    2 Texas Institute for Hip and Knee Surgery Austin Texas United States 78751
    3 Texas Orthopedics Austin Texas United States 78759
    4 Spokane Joint Replacement Center Spokane Washington United States 99218

    Sponsors and Collaborators

    • Medacta USA

    Investigators

    • Study Director: Mukesh Ahuja, MBBS, MS, Medacta USA, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medacta USA
    ClinicalTrials.gov Identifier:
    NCT02501733
    Other Study ID Numbers:
    • 121416-01
    First Posted:
    Jul 17, 2015
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Medacta USA
    Total Knee Replacement
    Total Knee Arthroplasty
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of May 25, 2022