None listed
Conditions
Brief summary
The aim of the study is to determine whether rasping (freshening using a surgical instrument) of the surface of the femur (thigh bone) prior to re-attachment of tendons routinely detached to perform total hip replacement improves their healing to the femur and their function as stabilisers during walking and standing on one leg after hip replacement. Pre-study statistical analysis performed by Mr Cameron Walker, Statistician from the University of Auckland. Desired power 80%. Desired significance level 0.05. Effect size 0.5. 50 patients required in each group for one-sided tests of significance. The analysis was performed using the “pwr” library in the R package. Block envelope Randomisation. First 100 consenting patients undergoing primary total hip replacement by either Mr Dray or Mr Bentall using a Hardinge’s approach analysed. Randomised to either closure of the abductor mechanism with or without rasping of the anterior femoral cortex prior to re-attachment. Surgical clips secured on both ends of abductor repair for radiographic analysis of repair integrity. All other aspects of surgery as per usual routine. Routine clinic follow-up post discharge at six weeks and six months. Assessment of patient’s gait for abductor lurch, trendelenbergs test and radiographic review with AP and lateral plain film X-rays of the hip. At the conclusion of the study Fisher’s exact test will be used to compare rates of abductor lurch, positive trendelenberg’s test and radiographic evidence of repair failure between the two groups.
Interventions
Rasping of anterior femoral cortex prior to abductor repair to the anterior femoral cortex in closure of the Hardinge's approach for total hip replacement.
The Hardinge's approach involves exposing the hip joint for total hip replacement by detaching the anterior one third of the insertion of gluteus medius and minimus on the anterior proximal femur (the 'abductors'). After the hip replacement has been completed this tendinous attachment is repaired using sutures.
Rasping the site of boney at
Rasping of anterior femoral cortex prior to abductor repair to the anterior femoral cortex in closure of the Hardinge's approach for total hip replacement. The Hardinge's approach involves exposing the hip joint for total hip replacement by detaching the anterior one third of the insertion of gluteus medius and minimus on the anterior proximal femur (the 'abductors'). After the hip replacement has been completed this tendinous attachment is repaired using sutures. Rasping the site of boney attachment of the abductors would involve using a surgical instrument called a rasp to roughen the smooth cortical boney surface and expose underlying vascular boney architecture. This may take an additional one to two minutes of operating time when compared to repair of the abductors without rasping. This is a one-off intervention at the time of closure of the Hardinge's exposure.
Sponsors
Hawkes Bay hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Primary total hip replacement using the hardinge’s approach. Pre-operative diagnosis of osteoarthritis or avascular necrosis.
Exclusion criteria
Pre-operative injury to the abductor mechanism. Rhemuatoid arthritis. Other connective tissue disease. Total hip replacement for fracture neck of femur. Current corticosteroid use. Current disease modifying anti-rheumatoid drug use. Neuromuscular disorder.
Outcome results
None listed