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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Oslo University Hospital
Sponsor:
Collaborators:
Betanien Hospital
Sykehuset Telemark
Vestre Viken Hospital Trust
Information provided by (Responsible Party):
Stephan M Rohrl, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01696552
First received: August 19, 2012
Last updated: September 27, 2012
Last verified: September 2012

August 19, 2012
September 27, 2012
September 2011
June 2013   (final data collection date for primary outcome measure)
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Measurement of knee implant positioning by using the CT Perth protocol
Same as current
Complete list of historical versions of study NCT01696552 on ClinicalTrials.gov Archive Site
  • Clinical Functional Result [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
    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.
  • Operating Time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Component Stability [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
    RSA
  • Cost to Benefit from a Health Economic Perspective [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cost-benefit analysis
  • X-ray analysis [ Time Frame: 10 yrs ] [ Designated as safety issue: Yes ]

    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.

  • Perioperative Morbidity [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
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)

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gonarthritis
  • 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
  • Procedure: TKR with Conventional Technique
    TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
    Other Name: Vanguard Total Knee System, Biomet
  • Active Comparator: TKR with Positioning Guides (PSPG)
    Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)
    Intervention: Procedure: TKR with Positioning Guides (PSPG)
  • Active Comparator: TKR with Conventional Technique
    TKR (Vanguard Total Knee System, Biomet), Conventional Technique
    Intervention: Procedure: TKR with Conventional Technique

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2020
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Stephan M Röhrl, MD, PhD +47-91502770 s.m.rohrl@medisin.uio.no
Contact: Justin van Leeuwen, MD +47-47337863 jamjvanleeuwen@gmail.com
Norway
 
NCT01696552
2011/7613, 2010/2056
No
Stephan M Rohrl, Oslo University Hospital
Oslo University Hospital
  • Betanien Hospital
  • Sykehuset Telemark
  • Vestre Viken Hospital Trust
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 Sykehuset Telemark
Oslo University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP