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CompletedNCT01135030AR vs PRUpdated Feb 6, 2012

Anterior Referencing Versus Posterior Referencing in Minimally Invasive Total Knee Arthroplasty

An interventional study of Total knee in Osteoarthritis, sponsored by Heekin Orthopedic Research Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-06.

Sponsored by Heekin Orthopedic Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to look at two different referencing systems for total knee replacement surgery. In anterior referencing system, referencing cuts are made from the front surface of the femur. This allows for a more exact cut. The anterior referencing system is more difficult for the surgeon to use. This may increase surgery time. Posterior referencing, on the other hand, references cuts from the back of the femur. The posterior referencing system is quick and easy for the surgeon to use. Posterior referencing may lead to notching of the femur. The risk of notching is very low and may not affect your results. This is a study that has never been done before. Dr. Heekin uses both referencing systems in his practice. He would like to determine which knee referencing system allows for greater knee flexion after surgery. Knee flexion correlates with function and the ability to return to everyday activities. For example, getting up from a chair, going up and down stairs, stooping, and kneeling.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • total knee arthroplasty
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Heekin Orthopedic Research Institute is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient is a male or non-pregnant female between the ages of 21-80.
  2. Patient requires cemented primary total knee replacement.
  3. Patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
  4. Patient has intact collateral ligaments.
  5. Patient has signed and dated an IRB approved study specific consent form.
  6. Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
  7. Patient has failed to respond to conservative treatment modalities.
  8. Patient's contralateral knee is without symptomatic degenerative disease.

Exclusion criteria

Exclusion Criteria:

  1. Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee.
  2. Patient is morbidly obese (BMI >30).
  3. Patient has a deformity at the involved knee greater than 45degrees of flexion, 45 degrees of varus or 45 degrees of valgus.
  4. Patient has an active or suspected latent infection in or about the knee joint.
  5. Patient has a malignancy in the area of the involved knee joint.
  6. Patient has a diagnosed systematic disease that would affect the subject's welfare or overall outcome of the study (i.e. moderate to severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
  7. Patient has a neurological deficit, which interferes with the patient's ability to limit weight bearing or places an extreme load on implant during the healing period.
  8. Female patient is or plans to become pregnant during the course of the study.
  9. Patient has a known sensitivity to device materials.
  10. Patient has prior diagnosis of diabetic or peripheral neuropathy in operative extremity or other neurologic disease affecting limb strength (i.e. Polymyositis, multiple sclerosis).
  11. Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
  12. Patient has a TKA on the contralateral side less than six months post-op.
  13. Patient has participated in an orthopaedic clinical investigation involving the hip or knee joint in the last 12 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Posterior referencing

    Procedure: Total knee

  • Active comparator
    Anterior referencing

    Procedure: Total knee

Interventions

  • ProcedureTotal knee

    Primary Total knee

06

What researchers measure

Primary outcomes

  1. greater flexion after surgery

    Time frame: 12 months

Secondary outcomes

  1. greater flexion after surgery

    Time frame: 24 months

07

Study locations

1 site
  • Heekin Orthopedic Specialists
    Jacksonville, Florida 32204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01135030
Lead sponsor
Heekin Orthopedic Research Institute
Collaborators
Stryker Orthopaedics
Responsible party
R. David Heekin (R. David Heekin, M.D., Heekin Orthopedic Research Institute) — Principal investigator
First posted
Jun 2, 2010
Start date
Oct 2006
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Feb 6, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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