Fixation Methods of Basicervical Fractures

NCT04240743 | Completed DMC

• 1 other identifier: 2015/514/74/7
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. The patients were allocated to one of two groups treated via cephalomedullary nail (CMN) or sliding hip screw (SHS). Functional and radiological evaluations was included the mobility score, Harris hip score, modified Barthel index, the Singh index, the tip-apex distance, and fracture settling.

Conditions

Hip Fractures; Osteoporotic Fractures

Keywords

Basicervical; Cervicobasiler; Hip; Fracture; Prospective randomized

Outcome Measures

Primary Outcomes (5)

• mobility score

  Functional outcome was assessed by the mobility score of Parker and Palmer (Parker MJ, Palmer CR (1993) A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br 75: 797-798), which uses a nine-point scale.

  12 months

• Harris hip score

  Hip function was rated with Harris Hip Score. The score has a maximum of 100 points (best possible function), covering pain (1 item, 0-44 points), function and activities (7 items, 0-47 points), and range of motion and absence of deformity (3 items, 0-9 points).

  12 months

• modified Barthel index

  Barthel Index (Mahoney FI, Barthel DW (1965) Functional evaluation: the Barthel Index. A simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill. Md State Med J 13:61-65), which measures the level of functional independence for 10 activities of daily living and ranges from 0 to 100.

  12 months

• the tip-apex distance

  It uses a numerical value (the distance between tip of screw and subchondral area) to show placement of the screw in the head: higher values indicating higher likelihood of fixation failure by extrusion of the screw.

  12 months

• fracture settling

  It uses a numerical value to show placement of shortening of the fractured femoral neck in time

  12 months

Study Arms (2)

cephalomedullary nail

ACTIVE COMPARATOR

Cephalomedullary nails was inserted and fixed to the femoral head. In this study, all patients were treated with short nails (Profin®, TST).

Device: cephalomedullary nail; Device: sliding hip screw

sliding hip screw

ACTIVE COMPARATOR

Sliding hip screws was inserted and fixed to the femoral head. In this study, all patients were treated with a side plate with three holes (DHS plate, TST).

Device: cephalomedullary nail; Device: sliding hip screw

Interventions

cephalomedullary nail DEVICE

For patients in the cephalomedullary nail group, an incision was made in the gluteal area from the tip of the greater trochanter in proximal orientation. A guidewire was placed into the medullary canal from slightly medial to the exact tip of the greater trochanter. The entry point of the greater trochanter and proximal medullary canal were reamed. The cephalomedullary nail was then inserted and fixed to the femoral head with a double screw. The cephalomedullary nail was then locked distally using a guide arm. These cephalomedullary nails were not locked proximally to maintain dynamization and to allow compression across the basicervical fracture line.

cephalomedullary nail; sliding hip screw

sliding hip screw DEVICE

For patients in the sliding hip screw group, a lateral incision was made over the lateral proximal aspect of the femur. Under fluoroscopic guidance, the lag screw was placed centrally in the femoral head over the guidewire. A side plate with three holes was then attached to the hip screw.

cephalomedullary nail; sliding hip screw

Eligibility Criteria

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

You may qualify if:

• basicervical fracture,
• age of ≥65 year,
• an isolated fracture,
• the ability to walk independently (with or without an aid) prior to fracture,
• a fracture that had occurred less than one week prior to admission.

You may not qualify if:

• history of ipsilateral femoral fracture,
• a fracture due to malignancy,
• limited life expectancy due to medical comorbidities,
• any contraindication to surgery,
• diagnosed dementia,
• any other traumatic fracture on admission.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

MeSH Terms

Conditions

Hip Fractures; Osteoporotic Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2016
• Primary Completion: December 27, 2017
• Study Completion: January 1, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01