Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures (TENPLA)

TENSION BAND VERSUS LOCKING PLATE FIXATION FOR THE TREATMENT OF PATELLA FRACTURE - a High Quality, Multicenter, Randomized Clinical Trial

This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Orthopedic Disorder; Patella Fracture
• Intervention / Treatment: Procedure: Tension band fixation; Procedure: Plate fixation

Detailed Description

This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.

Primary objective The overall objective of the study is to compare the 1-year patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS5) after standard tension band fixation with locking plat fixation for patients with patella fractures.

Secondary objectives Several other analyses are of interest and are planned but are not objectives of this study. Therefore, these analyses will, for the major part, hypothesis-generating. Analyses of this type include, but are not limited to harms, muscle atrophy, pain, general health, gait function, time to return to work and economical consequences between the two groups.

• Study Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rasmus Elsoe, MD, PhD; Phone Number: +4597660000; Email: rae@rn.dk
• Study Contact Backup: Name: Peter Larsen, PT, PhD; Phone Number: +4597660000; Email: peter.larsen@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Rasmus Joergensen, MD; Phone Number: +45 97 66 00 00; Email: rasjo@rn.dk
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Jeppe Barckman, MD, PhD; Phone Number: +457845 0000; Email: jeppbarc@rm.dk
  • Hjørring, Denmark, 9800
    • Recruiting
    • Regional Hospital Hjoerring
    • Contact: Predrag Kokanovic, MD; Phone Number: +4597640621; Email: p.kokanovic@rn.dk
  • Kolding, Denmark, 6000
    • Recruiting
    • Regional Hospital Kolding
    • Contact: Peter I Andersen, MD, PhD; Phone Number: +4576362000; Email: peter.ivan.andersen@rsyd.dk
  • Randers, Denmark, 8930
    • Recruiting
    • Regional Hospital Randers
    • Contact: Rikke Thorninger, MD; Phone Number: +4578420000; Email: rikkthor@rm.dk
  • Viborg, Denmark, 8800
    • Recruiting
    • Regional Hospital Viborg
    • Contact: Steffen S Jensen, MD; Phone Number: +4578440000; Email: steffen.skov@viborg.rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Above 18 years of age
• Patella fracture suitable for surgically treatment, with both surgical methods
• AO classification 34-B, 34-C

Exclusion Criteria:

• Open patella fracture above Gustillo grade 2
• Bilateral patella fracture
• Total knee replacement in the affected extremity
• Other fractures of the affected extremity within the previous 12 months.
• Other reasons for exclusion (unable to understand Danish, mentally unable to participate, etc).
• Prior ipsilateral patella fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tension band fixation; Surgical fixation of the patella fracture utilizing the AO principles using K-wires, screws, cerclage and sutures by surgeons choice.	Procedure: Tension band fixation; Fracture fixation of the patella fracture with tension band.
Experimental: Plate fixation; Surgical fixation of the patella fracture utilizing the AO principles and a locking plate with the number of screws by surgeons choice. Additional fixation by surgeons choice.	Procedure: Plate fixation; Fracture fixation of the patella fracture with a plate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score - (KOOS5)	The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.	One year following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score - (KOOS5)	The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.	3- and 6 months
Knee Injury and Osteoarthritis Outcome Score - subscales: pain, ADL, symptoms, sport and QOL.	The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.	3-, 6- and 12-months
EQ-5D-5L questionnaire (5-level version)	General health will be assessed using EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death.	3-, 6- and 12-months
Pain intensity measured on a 10 cm VAS scale	Development in pain will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.	3-, 6- and 12-months
"PainDETECT" questionnaire	Knee pain and neuropathic pain will be assessed using the "PainDETECT" questionnaire. The "PainDETECT" screening questionnaire uses a scoring method between 1-38. A total score of 1 indicates no symptoms, and 38 indicates major symptoms.	3-, 6- and 12-months
Bone union	Bone union, will be evaluated on standard AP and side X-rays of the fractured patella. The evaluation of bone union will be defined as: i) visible callus formation, diminished no visible fracture line and no pain from the fracture site at weight-bearing and at clinical examination.	3-, 6- and 12-months
Maximum isometric knee-extension strength	Maximum isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass. Will be measured bilaterally by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK)	12-months
Maximum isometric knee-flexion strength	Maximum isometric knee-flexion strength at 90 degrees knee flexion measured as Nm/kg body mass. Will be measured bilaterally by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK)	12-months
Knee range of motion	Knee range of motion. With the patient supine on an examination table the full range of passive motion in both knee joints will be measured using a standard goniometer.	3-, 6- and 12-months
Time to return to work	Measure the time from surgery to end of sick leave measured in days	3-, 6- and 12-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harms	Adverse events, defined as any negative or unwanted reactions to the two groups will be recorded. Based on previous reports we will focus on: infection, DVT and re-operation. Patients are continuously requested to report any suspicion of a potential AE. Furthermore, adverse events (AE) will be recorded at 3-, 6- and 12-months follow-up by asking patients about potential AEs using open-probe questioning to ensure that all AEs are recorded. Furthermore, medical records will be checked at the primary endpoint (12 months) for all AEs occurring from inclusion until the 12 months follow-up. An AE is defined as any undesirable experience during follow-up leading to contact with the healthcare system (general practitioner or hospital). If an AE result in hospitalization, prolonged inpatient hospital care, result in re-surgery, or if an AE is life-threatening, result in death, permanent disability or damage, they will be categorized as serious adverse events (SAEs).	3-, 6- and 12-months

Collaborators and Investigators

• Sponsor: Rasmus Elsøe
• Collaborators: Aarhus University Hospital; Viborg Regional Hospital; Randers Regional Hospital; Regional Hospital Hjoerring; Regional Hospital Kolding
• Investigators: Study Chair: Rasmus Elsoe, MD, PhD, Aalborg University Hospital, Denmark; Principal Investigator: Peter Larsen, PT, PhD, Aalborg University Hospital, Denmark

Publications and helpful links

Helpful Links

• The full study protocol are published online before study start

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: surgery; Plate; patella fracture; Tension band
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Musculoskeletal Diseases
• Other Study ID Numbers: LERG2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: A detailed statistical analysis plan will be made publicly available before the last patient is included in the study.

Drug and device information, study documents

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