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COMparison of Posterolateral and direct Anterior approach in uncemented total hip arthroplasty with a Short Stem prosthesis

COMparison of Posterolateral and direct Anterior approach in uncemented total hip arthroplasty with a Short Stem prosthesis - COMPASS Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46180
Enrollment
56
Registered
2017-06-07
Start date
2018-06-15
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degeneration osteoarthritis

Interventions

Two surgeons will be placing the NANOS stems. Both surgeons will use the direct anterior approach (DAA) and the posterolateral approach (PLA). Both surgeons have extensive experience with both these

Sponsors

Noordwest Ziekenhuisgroep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient is willing and able to participate in the study protocol Age between 18 and 75 years ASA Physical Status I & II Diagnosed with osteoarthritis of the hip Subjects for who it is decided that they will undergo an uncemented THA at Noordwest Ziekenhuis Groep, location Alkmaar.

Exclusion criteria

Exclusion criteria: Previous surgery to ipsilateral or contralateral hip. Patient has proven osteoporosis Pronounced coxa valga with a femoral neck angle > 145º Pronounced coxa vara with a femoral neck angle 30 Patients understanding of the language is insufficient for understanding the Patient Information and Consent

Design outcomes

Primary

MeasureTime frame
Radiographic analysis will be done on standard AP and lateral view X-rays postoperative, 8 weeks, 12 months and 24 months. Only the two X-rays that are taken during the extra outpatient appointment at 24 months do not include the standard treatment for THR. Migration and stem positioning analysis will be done using the EBRA-FCA system and is measured in mm.

Secondary

MeasureTime frame
Secondary study parameters are the clinical, functional and surgical outcome parameters compared between the DAA and PLA: * Perceived pain, measured using a Visual Analogue Scale (VAS) in the week before surgery, during hospitalization at days 1 to 3, at discharge, 6 weeks, three months, six months, one year after surgery and two years after surgey. * Hip pain and symptoms assessed using the symptoms, pain and activities of daily living (ADL) subscales of the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) in the week before surgery, at 6 weeks, three months, six months, one year after surgery and two years after surgey. * Hip range of motion in the week before surgery, at 6 weeks, three months, six months, one year after surgery and two years after surgey. * Quality of life assessed using the EQ-5D in the week before surgery, at 6 weeks, three months, six months, one year after surgery and two years after surgey. * Functioning during daily living assessed using the HOOS in the week before surgery, at 6 weeks, three months, six months, one year after surgery and two years after surgey. * Hip abductor strength and gait quality before surgery, at 6 weeks and after 12 months. * Length of hospital stay * Operation time, blood loss, and other parameters of the surgical procedures * All complications related to the surgery and rehabilitation * Health status will be classified using the ASA score. * Patient*s pre-operative status, surgical procedure as well as clinical and radiological outcome will be documented. 8.1.3 Other study parameters Patient characteristics such as age, gender, stature, body weight, body length, side of operation (left or right), smoking and comorbidities.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)