The Subvastus Approach in Total Knee Arthroplasty

• Sponsor: Nova Scotia Health Authority (Other)
• Overall Status: Completed
• CT.gov ID: NCT00346788
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Duration (Months): 73.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Procedure: Surgical approach for total knee arthroplasty	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Subvastus Approach in Total Knee Arthroplasty
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MIS minimally invasive incision	Procedure: Surgical approach for total knee arthroplasty; total knee arthroplasty surgery using minimally invasive surgery or standard technique.
Active Comparator: Standard Standard incision length	Procedure: Surgical approach for total knee arthroplasty; total knee arthroplasty surgery using minimally invasive surgery or standard technique.

Outcome Measures

Primary Outcome Measures

1. Length of hospital stay [Post Operative]

2. Range of motion at discharge and six weeks post-operatively [Discharge and six weeks post operative]

Secondary Outcome Measures

1. Wound complications [post operative until wound healed]

2. Post-operative narcotic use [24 months post operative]

3. Post-operative blood loss [Post operative]

4. The ability to straight-leg raise at two and twenty-four hours post-operatively [2 and 24 hours post operative]

5. Knee Society Clinical Rating Scale [pre-op, 6 months, 12 months, and 24 months post operative]

6. SF-12 [pre-op, 6 months, 12 months, and 24 months post operative]

7. WOMAC. [pre-op, 6 months, 12 months, and 24 months post operative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QEII Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 3A7

Sponsors and Collaborators

• Nova Scotia Health Authority

Investigators

• Principal Investigator: Ross K Leighton, MD, FRCS(C), Capital Health, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00346788
• Other Study ID Numbers: CDHA-RL-001
• First Posted: Jun 30, 2006
• Last Update Posted: Jun 28, 2011
• Last Verified: May 1, 2008

• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Jun 28, 2011