170 Participants NeededMy employer runs this trial

Knee Immobilization for Knee Replacement

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hospital for Special Surgery, New York

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether keeping the knee straight and immobile for 10 days after revision total knee arthroplasty can enhance knee movement three months later. Participants will either wear a brace for knee immobilization or follow the usual therapy with exercises immediately after surgery. The trial targets individuals undergoing knee surgery again due to issues like loosening or wear, excluding those having surgery for stiffness or certain other conditions.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could improve post-surgical outcomes.

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

The trial does not specify if you need to stop taking your current medications. However, if you are on pre-operative anticoagulation or have a history of high opioid use, you may not be eligible to participate.

What prior data suggests that knee immobilization is safe for postoperative recovery?

Research has shown that wearing a knee immobilizer brace after knee surgery can reduce the risk of falling. One study found that 502 patients who used the brace fell less often than those who did not, suggesting that the brace might make recovery safer.

However, evidence is less clear about other safety aspects, such as pain or knee function, when using a knee immobilizer. Some studies have examined the impact of knee braces on pain and knee function but have found mixed results. It is important to note that the knee immobilizer is not a new or experimental device and is commonly used in various knee treatments.

Overall, while the brace appears to lower the risk of falls, other safety factors might vary. Participants should consider these points and consult with their doctors to decide if joining a trial is appropriate for them.12345

Why are researchers excited about this trial?

Researchers are excited about the knee immobilization approach for knee replacement recovery because it could simplify early rehabilitation by eliminating knee range of motion exercises during the initial 10 days post-surgery. Unlike standard care where patients start physical therapy exercises immediately, this method uses a knee immobilizer brace to enhance healing by providing stability and reducing stress on the knee joint. This approach could potentially improve early postoperative recovery and reduce complications, offering a different path from traditional rehabilitation exercises.

What evidence suggests that knee immobilization is effective for improving knee joint range of motion after revision total knee arthroplasty?

This trial will compare the effects of knee immobilization with no immobilization after knee replacement surgery. Research has shown that using a knee brace after surgery can improve patient satisfaction with recovery. One study found that individuals using a straight leg brace reported better knee function and pain relief, with higher satisfaction one and two years post-surgery. However, another study indicated that prolonged use of a knee brace might lead to muscle weakness and reduced knee movement. Balancing the benefits of reduced pain and improved stability with the risk of muscle weakening is crucial. Overall, knee braces can aid in the short term, but careful use is necessary to avoid negative effects. Participants in this trial will either wear a knee immobilizer or not, to evaluate these outcomes.13678

Are You a Good Fit for This Trial?

This trial is for people having revision knee replacement surgery (not due to infection) because of issues like loosening, wear, instability, misalignment, or fracture. Both those getting one or both parts replaced can join.

Inclusion Criteria

I am having knee replacement surgery again for reasons not related to infection.
I am having a revision knee replacement surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision total knee arthroplasty (rTKA) and are assigned to either a knee immobilization protocol or standard physical therapy for 10 days postoperatively.

10 days
1 visit (in-person) for surgery, followed by daily monitoring

Follow-up

Participants are monitored for knee range of motion, swelling, stiffness, wound complications, and various functional scores at multiple timepoints postoperatively.

1 year
Multiple visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Knee Immobilization
  • No Knee Immobilizer

Trial Overview

The study compares two recovery methods after revision knee surgery: wearing a brace that keeps the knee straight and avoids movement exercises for 10 days versus starting standard physical therapy with movement right away.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Study GroupExperimental Treatment1 Intervention
Group II: Control GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Orthopaedic Research and Education Foundation (OREF)

Collaborator

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35587284/

Effect of joint immobilization using extension splint ...

Abstract · Purpose: Investigate the effect of semirigid extension bracing after total knee arthroplasty (TKA) on articular pain and function.

Effect of knee bracing on clinical outcomes following anterior ...

However, prolonged use of a knee brace can have negative consequences, such as muscle atrophy and a decline in function and proprioception. This is because the ...

Comparison of outcome following knee immobilization ...

The aim of this study is to compare the functional outcome and pain control in patients using knee immobilizer with those not using them in ...

Effect of joint immobilization using extension splint ...

The PS group was more likely to be satisfied with their outcome at 1 year (OR 1.75, p < 0.001) and at 2 years (OR 1.38, p = 0.001) when adjusting for ...

Reducing Costly Falls of Total Knee Replacement Patients

The objective of this study was to determine whether the use of a knee immobilizer brace reduces patient falls associated with the recent use of femoral ...

Knee Immobilization for Knee Replacement

The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23322911/

Reducing costly falls of total knee replacement patients

Of the 600 TKA patients who did not receive a knee immobilizer, 22 (3.7%) experienced a fall. In contrast, of the 502 patients who received knee immobilizers, ...

Reducing Costly Falls of Total Knee Replacement Patients

One proposed solution to mitigate the risk of falls in TKA patients receiving FNB is the use of knee immobilizer braces during postoperative ...