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

University of Oslo (UIO)

Status: Unknown

Conditions: Gonarthritis

Treatments: Procedure: TKR with Positioning Guides (PSPG); Procedure: TKR with Conventional Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01696552

2010/2056 (Other Identifier)

2011/7613

Details and patient eligibility

About

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)

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 2 patient groups

TKR with Positioning Guides (PSPG)

Active Comparator group

Description:

Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)

Treatment:

Procedure: TKR with Positioning Guides (PSPG)

TKR with Conventional Technique

Active Comparator group

Description:

TKR (Vanguard Total Knee System, Biomet), Conventional Technique

Treatment:

Procedure: TKR with Conventional Technique