Prospective Functional Outcome Study of the Knee

NCT02079493 | Terminated

• 1 other identifier: 11109-Conformis
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to obtain patient-oriented and clinically-oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty .

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee replacement; functional testing

Outcome Measures

Primary Outcomes (3)

• Functional testing

  Assess patient functional outcomes

  6 weeks post-op

• Functional testing

  Assess patient functional outcomes

  6 months post-op

• Functional testing

  Assess patient functional outcomes

  1-year post-op

Secondary Outcomes (3)

• Outcome questionnaires

  6-weeks post-op

• Outcome questionnaires

  6-months post-op

• outcome questionnaires

  1-year post-op

Study Arms (1)

Total Knee Arthroplasty patients

TKA patients

Device: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty DEVICE

Knee replacement

Also known as: ConforMIS, Off the shelf, TKA

Total Knee Arthroplasty patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total knee arthroplasty patients

You may qualify if:

• Patient is a male or non-pregnant female age 18 years or older at time of study
• Patient is a candidate for a total knee arthroplasty
• Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

• Patients younger than 18 years of age
• Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon
• Patients who have had any previous lower extremity procedure
• Patients with a BMI greater than or equal to 40
• Patients with an active infection within the affected knee joint Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
• Patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease)
• Patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
• Patient has a known sensitivity to device materials
• Non-English speaking patients
• Patient is a prisoner

Sponsors & Collaborators

• Tufts Medical Center: lead
• Restor3D: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Eric L Smith, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 5, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)