Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image DataNCT04960501
Comparison of Curative Effect Between New Tension Band and Patellar Tension Reduction Band in the Treatment of Lower Pole Fractures of Patella
An observational study of Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image Data, run by Peking University Third Hospital at 1 site in China.
Trial summary
Research purposes: Analyze the curative effect of the new tension band system composed of φ3.0mm hollow nails, titanium cables and new gaskets and the patellar tension reduction band in the treatment of lower pole fractures of the patella. Read more about this study
- Who is it for?
- Ages 22 to 79 years
- Conditions the study is for
- Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image Data
- What is being tested?
- New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2012to 1 Jul 2017
- 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 22 to 79 years
- All sexes
- Adult, Older adult
Study population: Among them, 19 were males and 22 were females, with an average age of 56.7 years (22 to 79 years)
Inclusion Criteria:Patients with comminuted fractures of the lower pole of the patella: AO/OTA type A1 and C1.3 type -
Exclusion Criteria:1. Except for other types of patella fractures 2. Except for open patella fractures 3. Excluding patients with other fractures and injuries 4. Exclude patients who cannot cooperate with functional exercises
-
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Research purposes:
Analyze the curative effect of the new tension band system composed of φ3.0mm hollow nails, titanium cables and new gaskets and the patellar tension reduction band in the treatment of lower pole fractures of the patella.
research method: A retrospective study of 41 cases of comminuted fractures of the lower pole of the patella treated with a new tension band system composed of φ3.0mm hollow nails, titanium cables and new spacers from March 2012 to July 2017, including 19 males and 22 females , The average age is 56.7 years (22 to 79 years), 24 cases of AO/OTA A1 type, and 17 cases of C1.3 type. During the same period, 22 cases of comminuted fractures of the lower pole of the patella were treated with a patella tension band, including 8 males and 14 females, with an average age of 57.4 years (32 to 84 years), 17 cases of AO/OTA type A1, and 5 cases of type C1.3. The injury mechanism is all slipping and kneeling injuries.
Read the detailed description
Research purposes:
Analyze the curative effect of the new tension band system composed of φ3.0mm hollow nails, titanium cables and new gaskets and the patellar tension reduction band in the treatment of lower pole fractures of the patella.
research method: A retrospective study of 41 cases of comminuted fractures of the lower pole of the patella treated with a new tension band system composed of φ3.0mm hollow nails, titanium cables and new spacers from March 2012 to July 2017, including 19 males and 22 females , The average age is 56.7 years (22 to 79 years), 24 cases of AO/OTA A1 type, and 17 cases of C1.3 type. During the same period, 22 cases of comminuted fractures of the lower pole of the patella were treated with a patella tension band, including 8 males and 14 females, with an average age of 57.4 years (32 to 84 years), 17 cases of AO/OTA type A1, and 5 cases of type C1.3. The injury mechanism is all slipping and kneeling injuries.
- Conditions
- Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image Data
- Being tested
- New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patellaProcedure or surgery
New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella
| Study group | Role | What they receive |
|---|---|---|
| New tension band system | Not described Receives: Procedure: New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella | |
| Patella reduction band system | Not described Receives: Procedure: New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
Measured: One day after surgery
Secondary outcomes (1)
Surgical bleeding
Measured: One day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Mar 2012
- Primary completion1 Mar 2012
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image DataStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960501
- Sponsor's protocol ID
- PekingUTH ZHS PF
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Curative Effect Between New Tension Band and Patellar Tension Reduction Band in the Treatment of Lower Pole Fractures of Patella
- ClinicalTrials.gov ID
- NCT04960501
- Acronym / sponsor ID
- PekingUTH ZHS PF
- Conditions
- Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Mar 2012 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 14 Jul 2021 (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.
Research purposes:
Analyze the curative effect of the new tension band system composed of φ3.0mm hollow nails, titanium cables and new gaskets and the patellar tension reduction band in the treatment of lower pole fractures of the patella.
research method: A retrospective study of 41 cases of comminuted fractures of the lower pole of the patella treated with a new tension band system composed of φ3.0mm hollow nails, titanium cables and new spacers from March 2012 to July 2017, including 19 males and 22 females , The average age is 56.7 years (22 to 79 years), 24 cases of AO/OTA A1 type, and 17 cases of C1.3 type. During the same period, 22 cases of comminuted fractures of the lower pole of the patella were treated with a patella tension band, including 8 males and 14 females, with an average age of 57.4 years (32 to 84 years), 17 cases of AO/OTA type A1, and 5 cases of type C1.3. The injury mechanism is all slipping and kneeling injuries.
Detailed description
Research purposes:
Analyze the curative effect of the new tension band system composed of φ3.0mm hollow nails, titanium cables and new gaskets and the patellar tension reduction band in the treatment of lower pole fractures of the patella.
research method: A retrospective study of 41 cases of comminuted fractures of the lower pole of the patella treated with a new tension band system composed of φ3.0mm hollow nails, titanium cables and new spacers from March 2012 to July 2017, including 19 males and 22 females , The average age is 56.7 years (22 to 79 years), 24 cases of AO/OTA A1 type, and 17 cases of C1.3 type. During the same period, 22 cases of comminuted fractures of the lower pole of the patella were treated with a patella tension band, including 8 males and 14 females, with an average age of 57.4 years (32 to 84 years), 17 cases of AO/OTA type A1, and 5 cases of type C1.3. The injury mechanism is all slipping and kneeling injuries.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New tension band system | – | Procedure: New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella |
| Patella reduction band system | – | Procedure: New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Among them, 19 were males and 22 were females, with an average age of 56.7 years (22 to 79 years)
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 |
|---|---|---|
| New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patellaNew type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella | Procedure or surgery | New tension band system, Patella reduction band system |
Primary outcome
operation time
Time frame: One day after surgery
1 secondary outcome
Surgical bleeding
Time frame: One day 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 14 Jul 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image Data, 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?
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 14 Jul 2021. 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?
operation time (time frame: One day after surgery). 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 14 Jul 2021.