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

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ClinicalTrials.gov Identifier: NCT01696552
Recruitment Status : Active, not recruiting
First Posted : October 1, 2012
Last Update Posted : March 29, 2017
Sponsor:
Collaborators:
Betanien Hospital
Sykehuset Telemark
Vestre Viken Hospital Trust
Information provided by (Responsible Party):
Stephan M Rohrl, Oslo University Hospital

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Gonarthritis Procedure: TKR with Positioning Guides (PSPG) Procedure: TKR with Conventional Technique Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.
Study Start Date : September 2011
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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 Name: Vanguard Total Knee System, Biomet



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. Operating Time [ Time Frame: 1 day ]
  3. Component Stability [ Time Frame: 2 yrs ]
    RSA

  4. Cost to Benefit from a Health Economic Perspective [ Time Frame: 1 year ]
    Cost-benefit analysis

  5. 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.


  6. Perioperative Morbidity [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696552


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

Additional Information:
Publications:

Responsible Party: Stephan M Rohrl, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01696552     History of Changes
Other Study ID Numbers: 2011/7613
2010/2056 ( Other Identifier: Regional Committee for Medical Health Research Ethics West )
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Stephan M Rohrl, Oslo University Hospital:
Gonarthritis
TKR
Conventional
Positioning Guides
PSPG
CT Perth

Additional relevant MeSH terms:
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