Extension LagNCT05833152
Correlation Between Preoperative Knee Extension Lag and Functional Outcome After Total Knee Arthroplasty
An observational study of Extension Lag and Total Knee Arthroplasty, run by Peking University Third Hospital at 1 site in China.
Trial summary
To explore the relationship between different knee extension hysteresis angles and functional outcome of knee joint after total knee replacement Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Extension Lag, Total Knee Arthroplasty
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 May 2024
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Department of Orthopaedics of Peking University Third Hospital for total knee arthroplasty
Who may be able to join
- (1) Patients who meet the diagnostic criteria of knee osteoarthritis (age >45 years old); (2) Patients admitted to the Department of Orthopedics of the Third Hospital of Beijing Medical University and preparing to receive TKA surgery; (3) The patient has good cognitive function and good compliance, and can cooperate with various examinations; (4) Voluntarily participate in the study and sign the informed consent;
Who cannot join
- (1) Patients with lower extremity fracture and severe lumbar spinal stenosis that affect postoperative functional recovery; (2) Patients with severe cerebrovascular disease who cannot cooperate with postoperative rehabilitation exercise; (3) The time interval of double knee replacement was less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Analysis of Knee Extension Lag Angle and Knee Function After Total Knee Arthroplasty
To explore the relationship between different knee extension hysteresis angles and functional outcome of knee joint after total knee replacement
Read the detailed description
- Collect perioperative baseline data Subjects were recruited and perioperative baseline data were collected: ① Demographic information, including age, sex, height, weight, affected knee, etc. ②Body structure and function: joint motion, knee extension hysteresis angle, pain NRS, WOMAC assessment, and ultrasonic knee extension mechanism were measured before and 3 days after surgery.
- Postoperative follow-up The patients were followed up for 3 months, and 6 weeks /3 months after surgery was selected as the follow-up node. The follow-up included postoperative range of motion, knee extension hysteresis Angle, pain NRS, WOMAC assessment, ultrasonic measuring knee extension mechanism, TUG Test (Timed Up-to-go Test), isometric muscle force test, balance postural graph, gait analysis, etc.
- Data analysis
- Multi-factor regression analysis was performed to determine the main outcome indicators of WOMAC evaluation at 3-month follow-up, including range of motion, Angle of knee extension hysteria, pain NRS, ultrasonic knee extension device, TUG Test (Timed Up-to-go Test), isoktatic muscle force test, balance postural graph and secondary outcome indicators of gait analysis. The perioperative knee extension hysteresis Angle was used as the independent variable to construct the postoperative regression model of knee function.
- According to the Angle of knee extension hysteresis in perioperative period, patients were divided into 4 groups: ≤5°, 5-10°11-15°, ≥15°, The results of range of motion, knee extension hysteresis Angle, pain NRS, WOMAC score, ultrasonic knee extension device, TUG Test (Timed Up to go Test), iso-tachykinesis test, balance postural mapping and gait analysis were compared among all groups 3 months after surgery.
- Study outcome
Follow-up was completed; The patient underwent revision surgery for knee osteoarthritis. The patient dropped out of the trial for personal reasons; Other unforeseen circumstances prevented the patient from continuing the trial.
- Conditions
- Extension Lag, Total Knee Arthroplasty
- Being tested
- total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
To observe the postoperative functional outcome of patients with knee extension lag at different angles
| Study group | Role | What they receive |
|---|---|---|
| <5° | Not described Receives: Procedure: total knee arthroplasty | |
| 5-10° | Not described Receives: Procedure: total knee arthroplasty | |
| 10-15° | Not described Receives: Procedure: total knee arthroplasty | |
| ≥15° | Not described Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Knee functional scale
Measured: three months after surgery
Secondary outcomes (2)
Thickness of vastus medialis muscle
muscle thickness
Measured: three months after surgery
range of motion
Reflect knee function
Measured: three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 May 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extension LagStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang yanyan, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833152
- Sponsor's protocol ID
- M2022846
- Status last verified
- May 2023
- First submitted
- 17 Apr 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGinn TL, Etcheson JI, Gwam CU, George NE, Mohamed NS, Mistry JB, Ananaba U, Bhave A. Short-term outcomes for total knee arthroplasty patients with active extension lag. Ann Transl Med. 2018 Jun;6(11):204. doi: 10.21037/atm.2018.05.38.
PubMed 30023367
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis of Knee Extension Lag Angle and Knee Function After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05833152
- Acronym / sponsor ID
- M2022846
- Conditions
- Extension Lag, Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Apr 2023 (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.
To explore the relationship between different knee extension hysteresis angles and functional outcome of knee joint after total knee replacement
Detailed description
- Collect perioperative baseline data Subjects were recruited and perioperative baseline data were collected: ① Demographic information, including age, sex, height, weight, affected knee, etc. ②Body structure and function: joint motion, knee extension hysteresis angle, pain NRS, WOMAC assessment, and ultrasonic knee extension mechanism were measured before and 3 days after surgery.
- Postoperative follow-up The patients were followed up for 3 months, and 6 weeks /3 months after surgery was selected as the follow-up node. The follow-up included postoperative range of motion, knee extension hysteresis Angle, pain NRS, WOMAC assessment, ultrasonic measuring knee extension mechanism, TUG Test (Timed Up-to-go Test), isometric muscle force test, balance postural graph, gait analysis, etc.
- Data analysis
- Multi-factor regression analysis was performed to determine the main outcome indicators of WOMAC evaluation at 3-month follow-up, including range of motion, Angle of knee extension hysteria, pain NRS, ultrasonic knee extension device, TUG Test (Timed Up-to-go Test), isoktatic muscle force test, balance postural graph and secondary outcome indicators of gait analysis. The perioperative knee extension hysteresis Angle was used as the independent variable to construct the postoperative regression model of knee function.
- According to the Angle of knee extension hysteresis in perioperative period, patients were divided into 4 groups: ≤5°, 5-10°11-15°, ≥15°, The results of range of motion, knee extension hysteresis Angle, pain NRS, WOMAC score, ultrasonic knee extension device, TUG Test (Timed Up to go Test), iso-tachykinesis test, balance postural mapping and gait analysis were compared among all groups 3 months after surgery.
- Study outcome
Follow-up was completed; The patient underwent revision surgery for knee osteoarthritis. The patient dropped out of the trial for personal reasons; Other unforeseen circumstances prevented the patient from continuing the trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| <5° | – | Procedure: total knee arthroplasty |
| 5-10° | – | Procedure: total knee arthroplasty |
| 10-15° | – | Procedure: total knee arthroplasty |
| ≥15° | – | Procedure: total knee arthroplasty |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Department of Orthopaedics of Peking University Third Hospital for total knee arthroplasty
Key inclusion criteria (1 listed)
- (1) Patients who meet the diagnostic criteria of knee osteoarthritis (age >45 years old); (2) Patients admitted to the Department of Orthopedics of the Third Hospital of Beijing Medical University and preparing to receive TKA surgery; (3) The patient has good cognitive function and good compliance, and can cooperate with various examinations; (4) Voluntarily participate in the study and sign the informed consent;
Key exclusion criteria (1 listed)
- (1) Patients with lower extremity fracture and severe lumbar spinal stenosis that affect postoperative functional recovery; (2) Patients with severe cerebrovascular disease who cannot cooperate with postoperative rehabilitation exercise; (3) The time interval of double knee replacement was less than 3 months.
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 |
|---|---|---|
| total knee arthroplastyTo observe the postoperative functional outcome of patients with knee extension lag at different angles | Procedure or surgery | 10-15°, 5-10°, <5°, ≥15° |
Primary outcome
WOMAC
Time frame: three months after surgery
Knee functional scale
2 secondary outcomes
Thickness of vastus medialis muscle
Time frame: three months after surgery
range of motion
Time frame: three months after surgery
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 3 Jun 2025.
- Background: PubMed 30023367McGinn TL, Etcheson JI, Gwam CU, George NE, Mohamed NS, Mistry JB, Ananaba U, Bhave A. Short-term outcomes for total knee arthroplasty patients with active extension lag. Ann Transl Med. 2018 Jun;6(11):204. doi: 10.21037/atm.2018.05.38.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Yang yanyan study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extension Lag and Total Knee Arthroplasty, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
WOMAC (time frame: three months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833152, which also lists 1 linked publication.
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 3 Jun 2025.