Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture

NCT06152198 | Recruiting

• 1 other identifier: Hipsther hip function
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Aim To investigate the effect of internal fixation versus hip arthroplasty on physical function and pain in elderly patients. Methods This is a substudy of an on-going nationwide multicenter registry-based RCT named HipSTHeR- (Hip Screws or Total Hip replacement or undisplaced femoral neck fracture in elderly patients) \[21\]. The aim is to recruit 340 patients with undisplaced or minimally displaced femoral neck fracture, Garden 1 or 2, are randomized to surgery either with internal screw fixation or hip arthroplasty. This substudy aims to investigate the potential differences between internal fixation versus hip arthroplasty regarding physical function and pain 4- and 12- months after surgery. Those included in the main study will be contacted by letter a few weeks after the surgery to be invited to participate in a further study. The assessor will then contact the person by telephone to answer further questions and to obtain informed consent. The follow-ups will be conducted over telephone and mail at 4 and 12 months. During the follow-up the participants will answer questions about their functional level. Information on randomisation and fracture data will be acquired from the Swedish Fracture Register and treatment data from the Swedish Hip Arthroplasty Register. Primary outcome The New Mobility Score will be used as the primary outcome with follow-up at 4- and 12 months. Secondary outcome WOMAC will be used as an additional hip specific patient reported outcome. Activities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL. Patients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE). The Geriatric Depression Scale (GDS-15), which are developed to identify depressive symptoms. The Philadelphia Geriatric Center Morale Scale (PGCMS) and have been used in several studies including frail people living in residential care facilities and can be used among patients with cognitive impairment.

Conditions

Hip Fractures; Femoral Neck Fractures; Undisplaced Fracture; Treatment Complication; Internal Fixation; Complications; Arthroplasty Complications

Keywords

hip fracture; femoral neck fracture; treatment; hip arthroplasty; internal fixation

Outcome Measures

Primary Outcomes (1)

• New Mobility Score

  The New Mobility Score is an evaluation of patient's ability to perform: walking indoor, outdoor and shopping. Each item is scored between 0 and 3 (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) resulting in a total of 9 points.

  4- and 12 months

Secondary Outcomes (4)

• WOMAC

  4- and 12 months

• Katz ADL index

  4- and 12 months

• ALFI-MMSE

  4- and 12 months

• Philadelphia Geriatric Center Morale Scale (PGCMS)

  4- and 12 months

Study Arms (2)

Hip arthroplasty

EXPERIMENTAL

Operative treatment with hip arthroplasty i.e cemented total- or hemiarthroplasty.

Device: Treatment

Internal fixation

ACTIVE COMPARATOR

Operative treatment with internal fixation i.e screws, pins, hook pins, sliding hip device.

Device: Treatment

Interventions

Treatment DEVICE

Allocation to hip arthroplasty or internal fixation. The choice between hemi- or total hip arthroplasty in the arthroplasty group and type of osteosynthesis are the surgeon preference.

Hip arthroplasty; Internal fixation

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Undisplaced (Garden I-II) femoral neck fracture (within 72h)
• Treated at participating unit
• Informed consent
• Amenable for both treatment options
• Included in the Hipsther trial

You may not qualify if:

• No informed consent
• Pathological or stress fracture
• Peri-implant fracture

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Olof Wolf

Uppsala, Sweden

RECRUITING

Related Publications (5)

• Wolf O, Sjoholm P, Hailer NP, Moller M, Mukka S. Study protocol: HipSTHeR - a register-based randomised controlled trial - hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients. BMC Geriatr. 2020 Jan 21;20(1):19. doi: 10.1186/s12877-020-1418-2.

  PMID: 31964340 BACKGROUND

• Mukka S, Sjoholm P, Aziz A, Eisler T, Kadum B, Krupic F, Morberg P, Sayed-Noor A. A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial. Pilot Feasibility Stud. 2020 Jul 11;6:98. doi: 10.1186/s40814-020-00642-w. eCollection 2020.

  PMID: 32670600 BACKGROUND

• Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993 Sep;75(5):797-8. doi: 10.1302/0301-620X.75B5.8376443.

  PMID: 8376443 BACKGROUND

• Burgers PT, Poolman RW, Van Bakel TM, Tuinebreijer WE, Zielinski SM, Bhandari M, Patka P, Van Lieshout EM; HEALTH and FAITH Trial Investigators. Reliability, validity, and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index for elderly patients with a femoral neck fracture. J Bone Joint Surg Am. 2015 May 6;97(9):751-7. doi: 10.2106/JBJS.N.00542.

  PMID: 25948522 BACKGROUND

• Viberg B, Kold S, Brink O, Larsen MS, Hare KB, Palm H; SENSE collaborators. Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial. BMJ Open. 2020 Oct 10;10(10):e038442. doi: 10.1136/bmjopen-2020-038442.

  PMID: 33040011 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Olof Wolf, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Mukka, MD, PhD

CONTACT

+46730867111; erika.olofsson@umu.se

Erika Olofsson, RN

CONTACT

erika.olofsson@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: June 20, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

SE (1)