Direct Superior approach versus PosteroLateral Approach in total Hip arthroplasty:;a multicenter double blinded randomized controlled trial

Direct Superior approach versus PosteroLateral Approach in total Hip arthroplasty:;a multicenter double blinded randomized controlled trial - SPLAsH

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51460

Enrollment

211

Registered

2022-12-08

Start date

2024-03-26

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

coxarthrosis hip athrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Symptomatic incapacitating coxarthrosis in whom total hip arthroplasty (THA) is indicated - Ageing 18 years and older at time of study entry - Competent and able to participate in follow-up

Exclusion criteria

Exclusion criteria: - Previous ipsilateral hip surgery - BMI >35 kg/m2 - Controlateral incapacitating coxarthrosis - Neurological conditions influencing walking pattern - Inability to walk without walking aid preoperatively - Rheumatoid arthritis (RA) - Severe hip dysplasia - Cognitive impairment - Inability to speak and write Dutch language

Design outcomes

Primary

Measure	Time frame
As primary outcome specifically the Hip Disability and Osteoarthritis Outcome Score- Physical Function Short Form (HOOS-PS) is used.	—

Secondary

Measure	Time frame
Secondary parameters/endpoints are split up into different categories. 1) HRQoL evaluation on the long term using PROMS (NRS score, Short form-12, HOOS subscales, Global rating of change, and Euro Quality of Life questionnaire). 2) physical function using physical functioning test (Timed Up and Go test and 40-meter self-paced walk test for hip osteoarthritis. 3) muscle atrophy measurements using CT-scans. Muscle atrophy is expressed in both quantity of muscle volume loss and the extend of fatty infiltration using the Goutallier scale. Component placement is measured in different angles. Other study parameters include preoperative demographics such as age and gender, perioperative data such as blood loss, use of analgetics, operation time and postoperative complications such as infection, aseptic loosening and dislocation.	—

Measure

Time frame

Secondary parameters/endpoints are split up into different categories. 1) HRQoL evaluation on the long term using PROMS (NRS score, Short form-12, HOOS subscales, Global rating of change, and Euro Quality of Life questionnaire). 2) physical function using physical functioning test (Timed Up and Go test and 40-meter self-paced walk test for hip osteoarthritis. 3) muscle atrophy measurements using CT-scans. Muscle atrophy is expressed in both quantity of muscle volume loss and the extend of fatty infiltration using the Goutallier scale. Component placement is measured in different angles. Other study parameters include preoperative demographics such as age and gender, perioperative data such as blood loss, use of analgetics, operation time and postoperative complications such as infection, aseptic loosening and dislocation.

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Countries

Netherlands

Outcome results