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The Subvastus Approach in Total Knee Arthroplasty

N

Nova Scotia Health Authority (NSHA)

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis

Treatments

Procedure: Surgical approach for total knee arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00346788
CDHA-RL-001

Details and patient eligibility

About

The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.

Enrollment

126 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • You are willing to take part in the study, including signing this form after carefully reading it.
  • You are available for follow-up for a minimum of 24 months (2 years).
  • You have no medical conditions that prevent you from having surgery.
  • This is the primary (first) knee replacement for this knee
  • You are fluent in English and are able to understand your responsibilities in this study.

Exclusion criteria

  • Active, local or systemic infection
  • Fibromyalgia or other chronic pain syndrome
  • Inability to follow the study requirements
  • Had this knee replaced before
  • Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
  • Body Mass Index (BMI) > 35, as you would not be eligible for the MIS approach.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

126 participants in 2 patient groups

MIS
Experimental group
Description:
minimally invasive incision
Treatment:
Procedure: Surgical approach for total knee arthroplasty
Standard
Active Comparator group
Description:
Standard incision length
Treatment:
Procedure: Surgical approach for total knee arthroplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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