Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty

March 27, 2017 updated by: Stephan M Rohrl, Oslo University Hospital

Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.

A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise) using the Vanguard Total Knee System (Biomet)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Use of PSPG in TKR is a relative new technique and already widely used. PSPG, based on MRI data, fit directly into the patient's anatomy and enable total knee replacement without use of traditional invasive instrumentation. Data showing extra benefit of this technique compared to conventional TKR technique are not widely available.

Aim: To determine the safety of this new surgical technique compared to conventional TKR and whether a clinical, functional and financial benefit can be achieved.

Methods: 200 patients with primary osteoarthritis will be randomized to 2 groups. 30 patients in each group will be included in the RSA section of the study. Participating hospitals UOS Ullevål, Vestre Viken, Sykehuset Telemark and Betanien Hospital Skien. Inclusion started Aug. 2011. Clinical scoring: KSS, KOOS, EQ-5D and VAS will be examined at inclusion, after 3 months, and at the 1 and 2 year control. RSA before discharge on day 2, 3 months, 1 year, 2 years. RSA images will be sent blinded to CIRRO (Center for Implant and Radiostereometric Research Oslo Orthopaedic Centre, Oslo University Hospital) for image analysis. Standing HKA: preoperatively and after 3 months. X-ray will be taken pre-operatively, postoperative day 3, after 3 months and after 5 and 10 years. CT Perth after 3 months for measuring alignment. A cost-benefit analysis will be performed.

Study Type

Interventional

Enrollment (Anticipated)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Buskerud
      • Drammen, Buskerud, Norway, 3004
        • Vestre Viken HF
    • Olso
      • Oslo, Olso, Norway, 0407
        • Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital
    • Telemark
      • Skien, Telemark, Norway, 3710
        • Sykehuset Telemark
      • Skien, Telemark, Norway, 3722
        • Betanien Hospital Skien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Man and women elder than 18 years old with knee osteoarthritis
  2. Informed consent

Exclusion Criteria:

  1. Active infection.
  2. Under 50 years.
  3. Revision arthroplasty.
  4. Marked bone loss which could preclude adequate fixation of the device.
  5. Non-cooperative subjects.
  6. Parkinson's Disease or other neurologic and muscular disorders
  7. Severe vascular insufficiency of the affected limb.
  8. Severe instability or deformity of the ligaments and / or surrounding soft tissue which may preclude stability of the device.
  9. Paget's disease
  10. Rheumatoid Arthritis and other systemic diseases
  11. Patients with rigid hip joints
  12. Known metal allergy
  13. Patients can only join the study with 1 operated knee arthroplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TKR with Positioning Guides (PSPG)
Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)
Procedure: TKR with Positioning Guides (PSPG)
TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
Other Names:
  • Vanguard Total Knee System, Biomet
  • Signature, Materialise
Active Comparator: TKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet), Conventional Technique
Procedure: TKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
Other Names:
  • Vanguard Total Knee System, Biomet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
Time Frame: 3 months
Measurement of knee implant positioning by using the CT Perth protocol
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Functional Result
Time Frame: 2 yrs
KOOS (Knee injury and Osteoarthritis Outcome Score), American knee society score, EQ-5D and pain score (NRS) will be registered pre-operatively, after 3 months and after 1 and 2 years. Scores of the 2 groups will be compared.
2 yrs
Operating Time
Time Frame: 1 day
1 day
Component Stability
Time Frame: 2 yrs
RSA
2 yrs
Cost to Benefit from a Health Economic Perspective
Time Frame: 1 year
Cost-benefit analysis
1 year
X-ray analysis
Time Frame: 10 yrs

Standing HKA (Hip, Knee, Ankle-long axis images): preoperatively and after 3 months. If there is a extension deficit a X-HKA will be performed 12 months postoperatively.

X-ray front, side and patella 'sky view' will be taken pre-operatively, postoperative day 3, after 5 and 10 years. Alignment and possible osteolytic development will be recorded in both groups.
10 yrs
Perioperative Morbidity
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Vestre Viken Hospital Trust
Sykehuset Telemark
Betanien Hospital

Investigators

  • Principal Investigator: Stephan M Röhrl, MD, PhD, Oslo Univerity Hospital, Oslo, Norway
  • Principal Investigator: Justin van Leeuwen, MD, Betanien Hospital Skien, Skien, Norway
  • Principal Investigator: Bjarne Grøgaard, MD, PhD, Oslo University Hospital, Oslo, Norway
  • Principal Investigator: Finnur Snorrason, MD, PhD, Vestre Viken HF, Drammen Hospital, Drammen, Norway
  • Principal Investigator: Hilde Apold, MD, PhD, Sykehuset Telemark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 19, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

October 1, 2012

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/7613
  • 2010/2056 (Other Identifier: Regional Committee for Medical Health Research Ethics West)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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