CompletedNCT02912351Updated Apr 1, 2022

A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis

An observational study in Osteoarthritis, sponsored by Medacta USA. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-04-01.

Sponsored by Medacta USA (part of Medacta International SA) · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 24
Sex: All

Study summary

This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.

Conditions studied

Osteoarthritis

Browse trials for

Osteoarthritis 4,445

Keywords

Total Knee Arthroplasty
Total Knee Replacement
Revision Knee Arthroplasty

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 803 observational studies indexed under Osteoarthritis.

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Lead sponsor

Medacta USA is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Browse Medacta USA studies →All Medacta International SA studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
Patients with ability to understand and provide written authorization for use and disclosure of personal health information
Patients must be willing to comply with the post-operative evaluation schedule.
Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
Patients must have received a GMK Revision component
Patients must be at minimum 2 year (24 months) post-treatment
The operation was performed or supervised by the investigator.
No age limit criteria

Exclusion criteria

Exclusion Criteria:

History of alcoholism
Currently on chemotherapy or radiation therapy
Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
History of chronic pain issues for reasons other than knee pain
Women that are pregnant

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 24 participants (actual)
Patient registry: No

Interventions

OtherPatient record review, Radiographs, and questionaires.
KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction

What researchers measure

Primary outcomes

Total Knee Society Scores (KSS)
Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.
Time frame: Minimum 2 years post surgery

Secondary outcomes

Radiographic Analysis
Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration and the presence and progression of radiolucent line between the prosthesis, bone and cement.
Time frame: Minimum 2 years post surgery
Patient Satisfaction
Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.
Time frame: Minimum 2 years post surgery
Complication Assessment
by reviewing Adverse Events
Time frame: minimum 2 years post surgery

Study locations

1 site

Saint Alphonsus Medical Group
Boise, Idaho 83706, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02912351
Lead sponsor: Medacta USA
Responsible party: Sponsor
First posted: Sep 23, 2016
Start date: Jan 2017
Primary completion: Mar 2022
Completion: Mar 2022
Last update: Apr 1, 2022

Study contacts

Mukesh Ahuja, MBBS, MS

study director · Medacta USA, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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