Treatment of Olecranon Fractures in the Elderly

Olecranon Fracture Clinical Trial

— CROFT2  

Official title:

Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - A Nordic Multicenter Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670900
• Other study ID #: REC2018/88
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Oslo University Hospital
• Contact: Frede Frihagen, PhD
• Phone: +4791332738
• Email: ffrihagen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.

Description:

Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Displaced olecranon fracture (Mayo 2A and 2B).

Exclusion Criteria:

• Associated fractures in the coronoid process, radial head or distal humerus.

• Open fracture, Gustilo-Andersen 2 or 3

• Severe cardiopulmonary disease or other medical condition which contraindicates surgery.

• Previous injury to or other condition in the elbow with serious functional impairment

Related Conditions & MeSH terms

• Fractures, Bone
• Olecranon Fracture
• Ulna Fractures

Intervention

Procedure:
• Tension band wiring or plate fixation
Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals.
• Active non-operative treatment with optional plaster cast
Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury.

Locations

Country	Name	City	State
Norway	Arendal Hospital	Arendal
Norway	Haukeland University Hospital	Bergen
Norway	Østfold Hospital Trust	Grålum
Norway	Vestre Viken Hospital Trust	Hønefoss
Norway	Diakonhjemmet Hospital	Oslo
Norway	Orthopedic Center, Ulleval University Hospital	Oslo
Norway	Baerum Hospital	Sandvika	Gjettum
Norway	Telemark Hospital	Skien
Norway	Stavanger University Hospital	Stavanger
Norway	Tønsberg Hospital	Tønsberg
Norway	St. Olavs Hospital	Trondheim	Trønderlag
Sweden	Akademiska Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

References & Publications (1)

Savvidou OD, Koutsouradis P, Kaspiris A, Naar L, Chloros GD, Papagelopoulos PJ. Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review. EFORT Open Rev. 2020 Aug 1;5(7):391-397. doi: 10.1302/2058-5241.5.190041. eCollection 2020 Jul. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Elbow Score	Patient reported 12 item form, 0 (worst) to 100 (best possible score)	52 weeks
Secondary	Range of motion	Extension, flexion, rotation	6 weeks
Secondary	Range of motion	Extension, flexion, rotation	12 weeks
Secondary	Range of motion	Extension, flexion, rotation measured in degrees total movement for each direction.	52 weeks
Secondary	Elbow extension strength	Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison.	6 weeks
Secondary	Elbow extension strength	Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison.	12 weeks
Secondary	Elbow extension strength	Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison.	52 weeks
Secondary	Elbow satisfaction	Single question: Are you satisfied with your elbow? Yes/Somewhat/No	6 weeks
Secondary	Elbow satisfaction	Single question: Are you satisfied with your elbow? Yes/Somewhat/No	12 weeks
Secondary	Elbow satisfaction	Single question: Are you satisfied with your elbow? Yes/Somewhat/No	52 weeks
Secondary	Complications	Serious local complications not reoperated.	Through study period up to 52 weeks.
Secondary	Number of Reoperations	Any reoperation	Through study period up to 52 weeks.
Secondary	Oxford Elbow Score	Patient reported 12 item form, 0 (worst) to 100 (best possible score)	6 weeks
Secondary	Oxford Elbow Score	Patient reported 12 item form, 0 (worst) to 100 (best possible score)	12 weeks