Comparison of Curative Effect Between New Tension Band and Patellar Tension Reduction Band in the Treatment of Lower Pole Fractures of Patella

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 Overview

• Status: Completed
• Conditions: Follow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image Data
• Intervention / Treatment: Procedure: New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Among them, 19 were males and 22 were females, with an average age of 56.7 years (22 to 79 years)

Description

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

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
New tension band system	Procedure: New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella; 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; New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
operation time	One day after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical bleeding	One day after surgery

Other Outcome Measures

Outcome Measure	Time Frame
Knee joint score after surgery	One week, one month, three months, six months after operation
Postoperative X-ray	One week, one month, three months, six months after operation
Follow-up body image data	One week, one month, three months, six months after operation

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2012
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (ACTUAL): July 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PekingUTH ZHS PF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No