Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02294747
• Date of registration: 12/11/2014
• Prospective Registration: No
• Primary sponsor: Oslo University Hospital
• Public title: Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA
• Scientific title: Trochanteric Hip Fractures (AO A2) Treated With Sliding Hip Screw With or Without Trochanteric Stabilizing Plate - a Randomized Controlled Trial Using Radiostereometry.
• Date of first enrolment: November 2014
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02294747
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Frede Frihagen, PhD
• Affiliation: Oslo University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- AO 31-A2

- able to walk independently, aids such as crutches or walker allowed

- able to consent

- fit for surgery with SHS with or without TSP

Exclusion Criteria:

- not willing or able to attain follow up

- previous fracture or surgery with retained metal work in the same hip

- concomitant disease that will shorten life expectancy



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Trochanteric Fractures

Hip Fractures

Intertrochanteric Fractures

Intervention(s)

Device: Sliding Hip Screw with Trochanteric Stabilization Plate

Device: Sliding Hip Screw without Trochanteric Stabilization Plate

Primary Outcome(s)

Fracture displacement during healing measured with radiostereometry [Time Frame: 52 weeks]

Secondary Outcome(s)

Harris Hip Score [Time Frame: 26 weeks]

Motion during healing as measured by radiostereometry. [Time Frame: 52 weeks]

Pain (NRS) [Time Frame: 26 weeks]

Satisfaction with operated hip (NRS) [Time Frame: 52 weeks]

Satisfaction with operated hip (NRS) [Time Frame: 8 weeks]

Timed Up and Go (Tug) test [Time Frame: 8 weeks]

Harris Hip Score [Time Frame: 52 weeks]

Harris Hip Score [Time Frame: 8 weeks]

Pain (NRS) [Time Frame: 8 weeks]

Timed Up and Go (Tug) test [Time Frame: 26 weeks]

Eq5d [Time Frame: 26 weeks]

Pain (NRS) [Time Frame: 4 weeks]

Pain (NRS) [Time Frame: 52 weeks]

Eq5d [Time Frame: 52 weeks]

Harris Hip Score [Time Frame: 4 weeks]

Pain (NRS) [Time Frame: 12 weeks]

Satisfaction with operated hip (NRS) [Time Frame: 12 weeks]

Time of surgery [Time Frame: 1 week]

Eq5d [Time Frame: 12 weeks]

Eq5d [Time Frame: 4 weeks]

Time to union as measured by plain radiographs and clinical findings [Time Frame: Will be examined at 4, 8, 12, 26 and 52 weeks]

Harris Hip Score [Time Frame: 12 weeks]

Motion during healing as measured by plain radiographs., [Time Frame: 52 weeks]

Timed Up and Go (Tug) test [Time Frame: 52 weeks]

Perioperative blood loss [Time Frame: 1 week]

Postoperative pain (NRS) while in hospital [Time Frame: 1 week]

Eq5d [Time Frame: 8 weeks]

Satisfaction with operated hip (NRS) [Time Frame: 26 weeks]

Time to union as measured by RSA (cessation of motion) and radiographs [Time Frame: Will be examined at 4, 8, 12, 26 and 52 weeks]

Satisfaction with operated hip (NRS) [Time Frame: 4 weeks]

Timed Up and Go (Tug) test [Time Frame: 12 weeks]

Timed Up and Go (Tug) test [Time Frame: 4 weeks]

Secondary ID(s)

2014/475/REK SO B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Diakonhjemmet Hospital