Clinical trial NCT01344421: Movement Pattern in Patients With Hip Dysplasia
Official title: Movement Pattern in Patients With Hip Dysplasia Operated With Minimally Invasive Approach in Peri-acetabular Osteotomy (PAO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Dysplasia
Keywords: Movement capture system
Movement analysis
Hip dysplasia
Hip pain
Quality of life
Physical function
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hip dysplasia and waiting for surgery.

Brief summary: The purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.

Detailed description: Congenital hip dysplasia is a disease characterised by pathological changes in the hip joint. Hip dysplasia is a normal disease with a prevalence of 4.3% in men and 3.6 in woman. Untreated hip dysplasia is a known cause of developing osteoarthritis early in life and symptoms as pain, hip instability together with a changed gait pattern are normal. Symptomatic hip dysplasia is seen in patients between 15 and 55 years and can be unilateral as well as bilateral. Causes of hip dysplasia are described as genetic, mechanic or hormonal.

Today patients with hip dysplasia are offered a hip conserving surgery before the osteoarthritis has developed. In 2003 a minimally invasive approach for periacetabular osteotomy (PAO) was introduced at Aarhus University Hospital. An advantage of minimally invasive approach compared to the classical Bernese periacetabular osteotomy is minimal impact of the soft tissues in the hip region.

Hip pain and activity limitations highly affect quality of life and physical function. The gait distance is reduced and patients have to compensate to relieve the pressure on the hip joint. Knowledge about the dynamics of the gait and running pattern in patients with dysplasia is important to understand the consequences of the dysplastic hip joint. Furthermore knowledge about gait compensations is relevant for the clinicians in the management and treatment of patients with hip dysplasia.

Today, gait and running compensation is unknown after minimally invasive approach The purpose of this study is, therefore, to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Peri-acetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hip dysplasia
* Patients in the age of 18-60 years
* Patients, who can speak, understand and read Danish

Exclusion Criteria:

* Persons with hip dysplasia secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.
* Persons who have had alloplastic surgery in the hip, knee or ankle.
* Persons with diseases that affect the gait pattern.
* Persons with serious hip, knee, ankle or back pain.

Primary outcomes:
measure: Hip flexion's muscle moment in stance evaluated in gait, run and jump test
timeFrame: Preoperative (baseline), 6 and 12 month postoperative
Secondary outcomes:
measure: Hip extension angle evaluated in gait, run and jump test
timeFrame: Preoperative (baseline), 6 and 12 month postoperative
measure: On-set of the hip muscles evaluated in gait, run and jump test
timeFrame: Preoperative (baseline), 6 and 12 month postoperative
measure: Function, sports and recreational activities
timeFrame: Preoperative (baseline), 6 and 12 month postoperative
measure: Quality of life
timeFrame: preoperative (baseline), 6 and 12 month postoperative
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Julie S Jacobsen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Inger Mechlenburg, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Kjeld Søballe, Prof. Dr.med
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Henrik Sørensen, PhD
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Dennis Nielsen, MSc
role: STUDY_CHAIR
References:
citation: Sorensen H, Skalshoi O, Nielsen DB, Jacobsen JS, Soballe K, Mechlenburg I. Hip muscle and joint contact forces before, 6 and 12 months after minimally invasive periacetabular osteotomy. Hip Int. 2021 Sep;31(5):676-682. doi: 10.1177/1120700020925411. Epub 2020 May 4.