Antero-Posterior Knee Stability

NCT03387839 | Completed

• 1 other identifier: SJRC-AP-Stability
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. Multiple implant brand/models will be included in the study.

Conditions

Osteoarthritis; Total Knee Arthroplasty; Stability; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Measurement of antero-posterior stability of the knee with stress x-rays.

  Antero-posterior stability of the knee will be measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion. Stress x-rays will be obtained during a single visit for subjects 1 year or greater post-operatively.

  1 year post-operative

Secondary Outcomes (3)

• Knee Society Score (KSS)

  1 year post-operative

• Lower Extremity Activity Scale (LEAS)

  1 year post-operative

• Forgotten Joint Score (FJS)

  1 year post-operative

Study Arms (3)

Medial-Pivot Knee Prosthesis

Other: Stress X-Ray

Posterior-Stabilized Knee Prosthesis

Other: Stress X-Ray

Cruciate-Stubstituting Knee Prosthesis

Other: Stress X-Ray

Interventions

Stress X-Ray OTHER

Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion

Cruciate-Stubstituting Knee Prosthesis; Medial-Pivot Knee Prosthesis; Posterior-Stabilized Knee Prosthesis

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Internal database of prior total knee replacement patients.

You may qualify if:

• Patients willing to sign the informed consent.
• Patients able to comply with study requirements including stress x-rays and self-evaluations.
• Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
• Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
• Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
• Patients with intact collateral ligaments.
• Range of motion within five degrees of full extension and a minimum of 120 degrees of flexion.

You may not qualify if:

• Patients with inflammatory arthritis.
• Patients that are morbidly obese, body mass index (BMI) \> 40.
• 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), excluding inhalers.
• 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.

Sponsors & Collaborators

• David F. Scott, MD: lead

Study Sites (1)

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David F Scott, MD

  Spokane Joint Replacement Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 2, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 2, 2018

Record last verified: 2017-12

Locations

US (1)