Hip Fractures Clinical Trial
— HipFunctOfficial 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
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.
Status | Recruiting |
Enrollment | 340 |
Est. completion date | September 1, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - No informed consent - Pathological or stress fracture - Peri-implant fracture - Previous inclusion of a contralateral Garden 1 or 2 femoral neck fracture |
Country | Name | City | State |
---|---|---|---|
Sweden | Olof Wolf | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University |
Sweden,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | WOMAC | 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. | 4- and 12 months | |
Secondary | Katz ADL index | 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. | 4- and 12 months | |
Secondary | ALFI-MMSE | 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. | 4- and 12 months | |
Secondary | Philadelphia Geriatric Center Morale Scale (PGCMS) | 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. | 4- and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02507609 -
Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium
|
N/A | |
Completed |
NCT03906864 -
Care Pathway for Sub-acute Hip Rehabilitation
|
N/A | |
Recruiting |
NCT04063891 -
Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients
|
N/A | |
Completed |
NCT05039879 -
Life Improving Factors After a Hip Fracture
|
||
Not yet recruiting |
NCT03887494 -
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)
|
N/A | |
Terminated |
NCT03065101 -
Trigen InterTAN vs Sliding Hip Screw RCT
|
N/A | |
Completed |
NCT03545347 -
Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.
|
Phase 2 | |
Completed |
NCT03695081 -
Patient Pathway Pharmacist - Optimal Drug-related Care
|
N/A | |
Recruiting |
NCT05971173 -
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
|
Early Phase 1 | |
Active, not recruiting |
NCT04957251 -
Anterior vs Posterior Approach for Hip Hemiarthroplasty
|
N/A | |
Terminated |
NCT04372966 -
Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures
|
N/A | |
Withdrawn |
NCT05030688 -
Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty
|
N/A | |
Completed |
NCT04424186 -
'Rehabilitation for Life'
|
N/A | |
Not yet recruiting |
NCT04183075 -
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
|
N/A | |
Withdrawn |
NCT05518279 -
Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures
|
Phase 3 | |
Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
Active, not recruiting |
NCT02247791 -
Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT00746876 -
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
|
N/A | |
Completed |
NCT00058864 -
The HIP Impact Protection Program (HIP PRO)
|
N/A |