Surgical Approaches for Total Knee Replacement

TL
Overseen ByThomas L Bradbury, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Total Joint Specialists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods for knee replacement: the Total Knee Arthroplasty Medial Parapatellar Approach and the Total Knee Arthroplasty Subvastus Approach. Researchers aim to determine which method aids better and faster recovery. Participants will receive a smart knee implant that tracks movement, enabling researchers to measure recovery through step count and other activity metrics. The trial seeks to identify significant differences in recovery based on the surgical approach. Individuals with longstanding knee issues planning a knee replacement with a Zimmer Persona IQ implant may be suitable candidates, especially if they can track pre-surgery activity using an iPhone. As an unphased trial, this study offers a unique opportunity to advance surgical techniques and improve recovery outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical approaches are safe for total knee replacement?

Previous studies have shown that both the medial parapatellar and subvastus approaches for total knee replacement are generally safe for patients. Research indicates that about 90% of patients undergoing total knee replacement report excellent or good outcomes, with successful results lasting over 10 years.

Specifically, studies show that the medial parapatellar approach is as safe in the midterm and long-term as other methods, with most patients recovering well.

The subvastus approach is also safe and well-tolerated. Some research suggests it might lead to better outcomes compared to the medial parapatellar approach. Both methods support quick recovery and good functional results.

Overall, these surgical approaches for knee replacement have a strong safety record, making them reliable options for patients considering this surgery.12345

Why are researchers excited about this trial?

Researchers are excited about these surgical approaches for total knee replacement because they offer different benefits compared to traditional methods. The Medial Parapatellar Approach is the most commonly used technique, which involves cutting through the quadriceps muscle to access the knee joint. In contrast, the Subvastus Approach avoids cutting through the muscle, potentially leading to less pain and quicker recovery since it preserves muscle integrity. Exploring these approaches can help determine which method offers better outcomes for patients, such as faster rehabilitation and improved long-term function.

What evidence suggests that this trial's surgical approaches could be effective for total knee replacement?

This trial will compare two surgical approaches for total knee replacement: the medial parapatellar approach and the subvastus approach. Research has shown that both methods are effective. Participants may receive the medial parapatellar method, known for its reliable results in knee surgeries and good outcomes for both short- and long-term recovery. Alternatively, participants may receive the subvastus method, which might offer early advantages. Studies have found that it can reduce pain, improve movement, and lead to faster recovery soon after surgery. In the long run, both methods result in similar improvements in knee function.36789

Are You a Good Fit for This Trial?

This trial is for individuals undergoing total knee replacement who will receive a Zimmer Persona IQ smart implant. Participants should be able to use an iPhone preoperatively and commit to follow-up for at least 6 months post-surgery. Specific eligibility criteria are not provided, but typically include adults in need of the surgery with no major health issues that would interfere with recovery or data collection.

Inclusion Criteria

I am over 18 and planning to have a specific knee replacement surgery.
I have an iPhone and agree to use it to track my steps for two weeks before surgery.
Provide informed consent
See 2 more

Exclusion Criteria

My knee can't fully straighten or bend properly.
I have had a knee replacement revision.
Patients with TKA other than medial congruent polyethylene bearing
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Monitoring

Preoperative activity is captured using iPhone Health step-count data

2 weeks

Surgery and Immediate Postoperative Monitoring

Primary total knee arthroplasty performed using either the medial parapatellar or subvastus approach, followed by continuous monitoring using the Persona IQ implant

30 days

Extended Follow-up

Participants are monitored for functional recovery and outcomes using continuous tibial implant data and surveys

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Total Knee Arthroplasty Medial Parapatellar Approach
  • Total Knee Arthroplasty Subvastus Approach

Trial Overview

The study compares two surgical techniques for knee replacement: medial parapatellar and subvastus approaches. It uses a smart implantable device to monitor patients' gait and activity levels before and after surgery, aiming to assess which approach leads to better early recovery based on step count, range of motion, walking speed, stride length, distance walked, pain levels, and patient-reported outcomes.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Subvastus ApproachActive Control1 Intervention
Group II: Medial Parapatellar ApproachActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Total Joint Specialists

Lead Sponsor

Citations

Comparative Analysis of Outcomes of Lateral Versus ...

Pooled data analysis from nine ... total knee arthroplasty: Clinical outcome and complications compared to medial parapatellar approach.

Perioperative outcomes of the quadriceps-sparing ...

We gathered data from 393 patients undergoing TKA, 352 (89.6 %) patients had an MPP approach and 41 (10.4 %) had an SV approach. When controlling for ...

A Systematic-Review and Network Meta-Analysis

No differences were found in functional outcomes over short or medium terms but subvastus seemed to increase the ROM at 6 months post-surgery.

Comparable long‐term functional outcomes of subvastus and ...

It is essential to note that the standard medial parapatellar approach is equally effective in achieving positive outcomes in TKA in the long- ...

Comparing the subvastus and medial parapatellar ...

The objective of this study was to compare the clinical outcomes of two surgical approaches-subvastus and medial parapatellar-in total knee ...

Comparisons of the Efficacy and Safety of Total Knee ...

Relevant studies have shown that approximately 90% of patients experience excellent or good TKA results, and the 10‐year survival of the ...

Comparing Early Functional Outcomes Between the ...

The midvastus approach showed non inferior outcomes when compared to the classic medial parapatellar approach and may confer additional functional benefits.

Clinical and Radiological Outcomes of Total Knee ...

Our data indicated that obesity can adversely influence the clinical and radiological outcomes after TKA performed by both MV and MPP approaches.

TKA Approaches - Recon

No midterm or longterm differences have been shown in terms of functional outcomes between a standard medial parapatellar, midvastus, ...