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

Surgery Clinical Trial

— TENPLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04891549
• Other study ID #: LERG2
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: December 2021
• Source: Aalborg University Hospital
• Contact: Rasmus Elsoe, MD, PhD
• Phone: +4597660000
• Email: rae[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Musculoskeletal Diseases
• Orthopedic Disorder
• Patella Fracture
• Surgery

Intervention

Procedure:
• Tension band fixation
Fracture fixation of the patella fracture with tension band.
• Plate fixation
Fracture fixation of the patella fracture with a plate.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Regional Hospital Hjoerring	Hjørring
Denmark	Regional Hospital Kolding	Kolding
Denmark	Regional Hospital Randers	Randers
Denmark	Regional Hospital Viborg	Viborg

Sponsors (6)

Lead Sponsor	Collaborator
Rasmus Elsøe	Aarhus University Hospital, Randers Regional Hospital, Regional Hospital Hjoerring, Regional Hospital Kolding, Regional Hospital Viborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	"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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to return to work	Measure the time from surgery to end of sick leave measured in days	3-, 6- and 12-months

External Links

•   The full study protocol are published online before study start