Roentgen Stereophotogrammetric Analysis (RSA) to Evaluate Fixation of Biofoam Advance Total Knee Arthroplasty Components

NCT00657956 | Completed

• 2 other identifiers: Dal07-02CDHA-RS/2007-250
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Hip and knee replacement arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a hip or knee arthroplasty is finite. This fact has largely been responsible for the continued development of new devices and techniques for joint arthroplasty surgery. Unfortunately, the introduction of new technologies and devices is not a benign process, and even subtle changes to existing implants can have a disastrous effect on patient outcome. The fact that new technologies and devices can lead to poor results has led some authors to advocate a phased introduction of new technologies. A key component of the phased introduction approach advocates the use of roentgen stereophotogrammetric analysis (RSA) early in the testing process. RSA is a highly accurate radiographic technique developed in Lund, Sweden and has for some time been the gold standard in Europe for assessing the stability of implants within bone. The purpose of this study is to utilize RSA to elucidate the migration patterns of the foam metal backed Advance Knee Arthroplasty components during the first 2 years postoperatively and to determine in what proportion of cases adequate fixation is achieved. In addition outcome measures will be recorded to quantify changes in functional status of subjects after surgery and bone mineral density will be monitored to quantify bone in-growth around the implant. Migration patterns will be compared to results obtained from previous studies of uncemented and cemented total knee arthroplasty components conducted at this centre.

Conditions

Osteoarthritis

Keywords

osteoarthritis; arthroplasty; knee joint; radiography; surgery; Bone Density; Outcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (1)

• micromotion of tibial component as measured with RSA

  2 years postoperative

Secondary Outcomes (2)

• Bone mineral density around the tibial component

  2 years postoperative

• Subjective health outcome questionnaires - SF36, WOMAC, Oxford12 knee, Pain and Catastrophizing Scale, Standardized comorbidity questionnaire

  2 years postoperative

Interventions

Advance Biofoam porous metal backed tibial component with or without screw augmentation DEVICE

total knee arthroplasty tibial component that has a backing of porous titanium metal to facilitate bone in-growth

Eligibility Criteria

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

You may qualify if:

• Symptomatic osteoarthritis of the knee indicating surgical intervention
• Between the ages of 21 and 80 inclusive
• Ability to give informed consent

You may not qualify if:

• Significant co-morbidity affecting ability to ambulate
• Flexion contracture greater than 15°
• Extension lag greater than 10°
• Tibial subluxation greater than 10 mm on standing AP radiograph
• Prior arthroplasty, patellectomy or osteotomy with the affected knee
• Lateral or medial collateral ligament instability (\> 10° varus/valgus)
• Leg length discrepancy greater than 10 mm
• Active or prior infection
• Morbid Obesity (BMI \> 40)
• Medical condition precluding major surgery
• Severe osteoporosis or osteopenia
• Neuromuscular impairment

Sponsors & Collaborators

• Dalhousie University: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Gross, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Michael J Dunbar, MD PhD

  Dalhousie University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 31, 2014

Record last verified: 2014-03

Locations

CA (1)