NCT00848133

Brief Summary

The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

4.6 years

First QC Date

February 19, 2009

Last Update Submit

February 19, 2009

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Knee Society Score

    Final follow-up (minimum 24 months)

Secondary Outcomes (1)

  • Radiographic alignment and fixation

    Final follow-up (minimum 24 months)

Study Arms (2)

mini-midvastus

ACTIVE COMPARATOR
Procedure: mini-midvastus surgical approach for total knee arthroplasty

mini-subvastus

ACTIVE COMPARATOR
Procedure: mini-subvastus surgical approach for total knee arthroplasty

Interventions

mini-midvastus surgical approach for total knee arthroplastyPROCEDURE
mini-midvastus
mini-subvastus surgical approach for total knee arthroplastyPROCEDURE
mini-subvastus

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with advanced bilateral osteoarthritis of the knee for treatment with total knee arthroplasty
  • patients who wish to undergo bilateral total knee arthroplasty as part of a single surgical procedure

You may not qualify if:

  • patients who were previously treated with knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bonutti Clinic

Effingham, Illinois, 62401, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Michael A Mont, MD

    Sinai Hospital of Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

July 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

US(1)