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

NCT02912351 | Completed DMC

• 1 other identifier: K102437-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis

Keywords

Total Knee Arthroplasty; Total Knee Replacement; Revision Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total Knee Society Scores (KSS)

  Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.

  Minimum 2 years post surgery

Secondary Outcomes (3)

• Radiographic Analysis

  Minimum 2 years post surgery

• Patient Satisfaction

  Minimum 2 years post surgery

• Complication Assessment

  minimum 2 years post surgery

Interventions

Patient record review, Radiographs, and questionaires. OTHER

KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (1)

Saint Alphonsus Medical Group

Boise, Idaho, 83706, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Mukesh Ahuja, MBBS, MS

  Medacta USA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: September 23, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (1)