HipFunct: Internal Fixation vs Hip Arthroplasty in Older Adults With an Undisplaced Femoral Neck Fracture: A Substudy of the Hipsther Trial

Sponsor

Uppsala University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06152198

Collaborator

(none)

340

Enrollment

Location

Arms

74.4

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures Femoral Neck Fractures Undisplaced Fracture Treatment Complication Internal Fixation; Complications Arthroplasty Complications	Device: Treatment	N/A

Detailed Description

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]. 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.

The inclusion criteria for the Hipsther trial are: >75 years and an undisplaced or minimally displaced femoral neck fracture, classified as Garden I or II on conventional radiograph, eligible for internal fixation and hip arthroplasty and treatment at participating unit. The exclusion criteria are pathological or stress fractures, peri-implant femoral neck fracture and previous inclusion of a contralateral Garden 1 or 2 femoral neck fracture. Patients with cognitive impairment are also included. The inclusion criteria for this substudy is inclusion in the Hipsther trial and the participants require a functional language in Swedish.

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. 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. The New Mobility Score (NMS) may predict mortality, predict function and has a high inter-tester reliability.

Secondary outcome WOMAC will be used as an additional hip specific patient reported outcome. The scale contains 24 items; divided in pain, stiffness and physical function, on a scale of 0 to 4, where lower score indicates a lower level of symptom and physical disability. WOMAC has been found to have good reliability and validity in elderly patients with femoral neck fracture and is widely used in the evaluation of hip osteoarthritis. The patients' pain will also be assessed with NRS, both in rest and activity. WOMAC will be assessed at 4- and 12 months follow-up.

Activities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL. The Katz ADL index measures both Personal-ADL (P-ADL, bathing, dressing, toileting, transfer, continence and feeding) and Instrumental ADL (I-ADL, cleaning, shopping, transportation, and cooking), higher scores indicating greater ADL dependence.

Patients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE). To discover depressive symptoms, we will use The Geriatric Depression Scale (GDS-15), which are developed to identify depressive symptoms with 15 "yes" or "no" questions, and higher scores indicating greater depressive symptoms. The participants subjective well-being or morale will be assessed with 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. The PGCMS has 17 dichotomized items, and the scores vary between 0 to 17, where a high morale is described as a basic sense of satisfaction with oneself and according to the instructions scores 0-9 indicates a low morale, 10-12 indicates intermediate and 13-17 high morale.

Sample size The sample size calculation was performed similarly to the Sense trial [34]. We assumed a minimal clinically important difference in NMS of 1 point and a 1-year average of 6.4 points with an SD of 2.2 [35]. Assuming a 1-point difference with an SD of 2.2, allowing a 5% probability of type 1 error for a 95% statistical power. 127 patients are required in each group. To allow for loss during follow-up due to mortality and internal dropout (25%). Therefore, a total of 340 patients are required for the study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

340 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Internal Fixation Versus Hip Replacement in Older Adults With an Garden I/II Femoral Neck Fracture: Physical Function and Pain in Elderly Patients - a Substudy of the Hipsther Trial

Actual Study Start Date :

Jun 20, 2021

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hip arthroplasty Operative treatment with hip arthroplasty i.e cemented total- or hemiarthroplasty.	Device: Treatment 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.
Active Comparator: Internal fixation Operative treatment with internal fixation i.e screws, pins, hook pins, sliding hip device.	Device: Treatment 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.

Arm

Intervention/Treatment

Experimental: Hip arthroplasty

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

Device: Treatment

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.

Active Comparator: Internal fixation

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

Device: Treatment

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.

Outcome Measures

Primary Outcome Measures

New Mobility Score [4- and 12 months]
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.

Secondary Outcome Measures

WOMAC [4- and 12 months]
An additional hip specific patient reported outcome. The scale contains 24 items; divided in pain, stiffness and physical function, on a scale of 0 to 4, where lower score indicates a lower level of symptom and physical disability [25]. WOMAC has been found to have good reliability and validity in elderly patients with femoral neck fracture [26] and is widely used in the evaluation of hip osteoarthritis. The patients' pain will also be assessed with NRS, both in rest and activity.
Katz ADL index [4- and 12 months]
Activities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL. The Katz ADL index measures both Personal-ADL (P-ADL, bathing, dressing, toileting, transfer, continence and feeding) and Instrumental ADL (I-ADL, cleaning, shopping, transportation, and cooking), higher scores indicating greater ADL dependence.
ALFI-MMSE [4- and 12 months]
Patients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE) [28]. To discover depressive symptoms, we will use The Geriatric Depression Scale (GDS-15) [29], which are developed to identify depressive symptoms with 15 "yes" or "no" questions, and higher scores indicating greater depressive symptoms.
Philadelphia Geriatric Center Morale Scale (PGCMS) [4- and 12 months]
The participants subjective well-being or morale will be assessed with 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. The PGCMS has 17 dichotomized items, and the scores vary between 0 to 17, where a high morale is described as a basic sense of satisfaction with oneself and according to the instructions scores 0-9 indicates a low morale, 10-12 indicates intermediate and 13-17 high morale.