Total Knee Arthroplasty (TKA)NCT03671954
Total Knee Arthroplasty Biomechanics
A study testing Home Strengthening Exercises, Standard Physical Therapy and Preoperative Assessments in people with Total Knee Arthroplasty (TKA), run by University of Florida at 4 sites in United States.
Trial summary
In total knee arthroplasty (TKA), the relationship between implant design, soft tissue balance, neuromuscular contributions, and rehabilitation strategies on patient satisfaction and functional outcomes is highly complex and poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty (TKA)
- What is being tested?
- Home Strengthening Exercises, Standard Physical Therapy and Preoperative Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 May 2019to 16 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring unilateral TKA for knee osteoarthritis
- No osteoarthritis symptoms in contralateral knee
- Radiographic coronal deformity ≤ 15°
- Preoperative flexion ≥ 90°
- Receiving one of four implants used by UF Orthopaedic surgeons
- Able to walk for a short distance without the use of ambulatory aids
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- Healthy Participants:
- Age 49-85 years
- Healthy with no signs or symptoms of lower limb arthritis or injury
- Able to walk for a short distance without the use of ambulatory aids
Who cannot join
- BMI > 40 kg/m2
- Presence of knee, hip, or ankle prosthesis for either limb
- Presence of hip prosthesis in surgical limb (TKA only subjects)
- History of lower limb or spinal surgery within the last year
- Presence of neurologic or orthopaedic disorders that could affect gait or balance
- Chronic opioid or illicit drug use
Show all 11Show fewer
- Poorly controlled diabetes (HbA1C > 7 percent)
- Chronic pain syndrome
- Chronic back pain
- Presence of vestibular disorder
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
UF Health Florida Surgical Center
Gainesville, Florida, 32607
UF Health at the University of Florida
Gainesville, Florida, 32610
UF Health Cancer Hospital
Gainesville, Florida, 32610
About this study
Official title: Determining the Effects of Implant Design, Soft Tissue Balance, Neuromuscular Adaptations, and Rehabilitation Strategies on Functional Outcomes and Patient Satisfaction After Total Knee Arthroplasty
In total knee arthroplasty (TKA), the relationship between implant design, soft tissue balance, neuromuscular contributions, and rehabilitation strategies on patient satisfaction and functional outcomes is highly complex and poorly understood. The investigators will prospectively study the effects of these factors using in vivo assessments preoperatively, and postoperatively. Computer simulation models will also be used to analyze lower extremity biomechanics.
Read the detailed description
Total knee arthroplasty (TKA) is the primary treatment for end-stage knee osteoarthritis and effectively relieves pain and improves function after surgery. Nevertheless, as many as 1 in 5 patients are dissatisfied with the postoperative outcome, and knee instability remains one of the top indications for revision surgery. Implant design, soft tissue balance, neuromuscular capabilities, and rehabilitation strategies can all influence postoperative outcomes. However, the relationship between these factors and the most effective therapeutic approach for total knee arthroplasty has yet to be identified. The investigators will study preoperative and postoperative functional measures and patient satisfaction along with implant design and specific intraoperative data, which may help inform a targeted approach for optimal outcomes after total knee arthroplasty and improve future care of patients.
- Conditions
- Total Knee Arthroplasty (TKA)
- Being tested
- Home Strengthening Exercises, Standard Physical Therapy, Preoperative Assessments
- Keywords
- knee osteoarthritis, rehabilitation strategies, soft tissue balance
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Strengthening ExercisesBehavioural
Also called Hip abductor strengthening program
The intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone.
Standard Physical TherapyOther
Physician determined standard of care for individual TKA patients.
Preoperative AssessmentsOther
Assessments will include:
- TUG (timed up and go test) >12 sec indicates increased fall risk
- Tandem balance test < 10 sec indicates increased fall risk
- Sit to Stand test (age based norms)
- Knee Range Of Motion (ROM)
- Quadriceps and hamstring strength (MMT or hand held dynamometer)
- Lower Extremity Functional Score (LEFS questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| TKA Intervention Group | Experimental | The TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy. Receives: Behavioral: Home Strengthening Exercises; Other: Standard Physical Therapy |
| TKA Control Group | Active comparator | The TKA control group will receive standard physical therapy alone. Receives: Other: Standard Physical Therapy |
| Healthy Control Group | Active comparator | The Healthy Control Group, aged 49-85 years without any signs of degenerative joint, disease will undergo the preoperative assessments only. Receives: Other: Preoperative Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Top declined walking speed before and after TKA.
Top walking speed is defined as the maximum speed a patient feels that they can safely walk without running. Patients will walk on an instrumented treadmill declined at seven degrees.
Measured: Tested preoperatively, and once during the two to four months after TKA
Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA
Maximum isometric quadriceps, hamstrings, and gluteus medius strength as measured by a dynamometer.
Measured: Tested preoperatively, and once during the two to four months after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 May 2019
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (TKA)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone. Subjects will be assigned to one of two groups by block randomization, such that patients receiving each different implant design comprise each block.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Orthosensor, Inc.
- Responsible party
- Sponsor
- Investigators
- MaryBeth Horodyski, EdD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671954
- Sponsor's protocol ID
- IRB201801019
- Other IDs
- OCR18180
- Status last verified
- Nov 2023
- First submitted
- 31 Aug 2018
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effects of Implant Design, Soft Tissue Balance, Neuromuscular Adaptations, and Rehabilitation Strategies on Functional Outcomes and Patient Satisfaction After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03671954
- Acronym / sponsor ID
- IRB201801019
- Conditions
- Total Knee Arthroplasty (TKA)
- Keywords
- knee osteoarthritis, rehabilitation strategies, soft tissue balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Orthosensor, Inc.
- Study start
- 1 May 2019 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In total knee arthroplasty (TKA), the relationship between implant design, soft tissue balance, neuromuscular contributions, and rehabilitation strategies on patient satisfaction and functional outcomes is highly complex and poorly understood. The investigators will prospectively study the effects of these factors using in vivo assessments preoperatively, and postoperatively. Computer simulation models will also be used to analyze lower extremity biomechanics.
Detailed description
Total knee arthroplasty (TKA) is the primary treatment for end-stage knee osteoarthritis and effectively relieves pain and improves function after surgery. Nevertheless, as many as 1 in 5 patients are dissatisfied with the postoperative outcome, and knee instability remains one of the top indications for revision surgery. Implant design, soft tissue balance, neuromuscular capabilities, and rehabilitation strategies can all influence postoperative outcomes. However, the relationship between these factors and the most effective therapeutic approach for total knee arthroplasty has yet to be identified. The investigators will study preoperative and postoperative functional measures and patient satisfaction along with implant design and specific intraoperative data, which may help inform a targeted approach for optimal outcomes after total knee arthroplasty and improve future care of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone. Subjects will be assigned to one of two groups by block randomization, such that patients receiving each different implant design comprise each block.
| Arm | Type | Receives |
|---|---|---|
| TKA Intervention Group | Experimental | Behavioral: Home Strengthening Exercises, Other: Standard Physical TherapyThe TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy. |
| TKA Control Group | Active comparator | Other: Standard Physical TherapyThe TKA control group will receive standard physical therapy alone. |
| Healthy Control Group | Active comparator | Other: Preoperative AssessmentsThe Healthy Control Group, aged 49-85 years without any signs of degenerative joint, disease will undergo the preoperative assessments only. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients requiring unilateral TKA for knee osteoarthritis
- No osteoarthritis symptoms in contralateral knee
- Radiographic coronal deformity ≤ 15°
- Preoperative flexion ≥ 90°
- Receiving one of four implants used by UF Orthopaedic surgeons
Key exclusion criteria (11 listed)
- BMI > 40 kg/m2
- Presence of knee, hip, or ankle prosthesis for either limb
- Presence of hip prosthesis in surgical limb (TKA only subjects)
- History of lower limb or spinal surgery within the last year
- Presence of neurologic or orthopaedic disorders that could affect gait or balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Strengthening ExercisesAlso: Hip abductor strengthening programThe intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone. | Behavioural | TKA Intervention Group |
| Standard Physical TherapyPhysician determined standard of care for individual TKA patients. | Other | TKA Control Group, TKA Intervention Group |
| Preoperative AssessmentsAssessments will include: * TUG (timed up and go test) >12 sec indicates increased fall risk * Tandem balance test < 10 sec indicates increased fall risk * Sit to Stand test (age based norms) * Knee Range Of Motion (ROM) * Quadriceps and hamstring strength (MMT or hand held dynamometer) * Lower Extremity Functional Score (LEFS questionnaire) | Other | Healthy Control Group |
Primary outcome
Top declined walking speed before and after TKA.
Time frame: Tested preoperatively, and once during the two to four months after TKA
Top walking speed is defined as the maximum speed a patient feels that they can safely walk without running. Patients will walk on an instrumented treadmill declined at seven degrees.
Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA
Time frame: Tested preoperatively, and once during the two to four months after TKA
Maximum isometric quadriceps, hamstrings, and gluteus medius strength as measured by a dynamometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MaryBeth Horodyski, EdD principal investigator
University of Florida
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Strengthening Exercises, Standard Physical Therapy and Preoperative Assessments in people with Total Knee Arthroplasty (TKA), run by University of Florida at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Top declined walking speed before and after TKA. (time frame: Tested preoperatively, and once during the two to four months after TKA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.