Difference in Patient Reported Outcomes at 1 year after 6 or 8 weeks of carpometacarpal joint distraction: a Randomized Controlled Non-Inferiority Trial.

Difference in Patient Reported Outcomes at 1 year after 6 or 8 weeks of carpometacarpal joint distraction: a Randomized Controlled Non-Inferiority Trial. - Joint distraction for CMC1 osteoarthritis: 6 versus 8 weeks.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48014

Enrollment

Registered

2019-08-09

Start date

2020-07-07

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

Trapeziometacarpal osteoarthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age

Exclusion criteria

Exclusion criteria: - Unable to attend follow-up appointments - Inflammatory or rheumatoid arthritis present or in history - >30% joint subluxation - Involvement of STT joint - Surgical treatment of the CMC joint in the past - Use of immunosuppressive or chemotherapeutic drugs - Hypermobility syndrome - Syndromatic diseases

Design outcomes

Primary

Measure	Time frame
The main study parameter is the PROMIS PF UE SF score at 12 months in both groups (6 versus 8 weeks of distraction). The PROMIS PF UE SF is a 16-item questionnaire with T-Scores. Average T-score among the general population is 50 points, with a standard deviation of 11 points. Higher scores indicate a better physical upper extremity function.	—

Secondary

Measure	Time frame
Second study parameters at 12 months: - MHQ scores: a validated questionnaire with scores from 0 - 100 with scores of 100 representing perfect physical function of the hand. - VAS scores for pain, satisfaction, function, and stiffness: with scores from 0 representing no pain at all or fully satisfied or optimal function to 100 worst pain possible or not at all satisfied or worst possible function. - Range of Motion: measured with Kapandji (score 0-9) and pollexograph (degrees) - Strength measures: grip, key, and tip strength (in kg) - Joint space on X-ray examination (in mm) - Dutch Patient Health Questionnaire (PHQ-2): 2-item questionnaire with scores from 0 representing lowest level of depression to 6 highest level of depression. -Dutch Pain Catastrophizing Scale (PCS-4): 4-item questionnaire rated on a 5-point Likert scale with scores ranging from 0 no catastrophic thinking to 16 worst possible catastrophic thinking. - Treating surgeon - Patient characteristics: gender, age, work status, marital status, level of education, years of CMC1 related symptoms.	—

Measure

Time frame

Second study parameters at 12 months: - MHQ scores: a validated questionnaire with scores from 0 - 100 with scores of 100 representing perfect physical function of the hand. - VAS scores for pain, satisfaction, function, and stiffness: with scores from 0 representing *no pain at all* or *fully satisfied* or *optimal function* to 100 *worst pain possible* or *not at all satisfied* or *worst possible function*. - Range of Motion: measured with Kapandji (score 0-9) and pollexograph (degrees) - Strength measures: grip, key, and tip strength (in kg) - Joint space on X-ray examination (in mm) - Dutch Patient Health Questionnaire (PHQ-2): 2-item questionnaire with scores from *0* representing *lowest level of depression* to *6* *highest level of depression*. -Dutch Pain Catastrophizing Scale (PCS-4): 4-item questionnaire rated on a 5-point Likert scale with scores ranging from *0* *no catastrophic thinking* to *16* *worst possible catastrophic thinking*. - Treating surgeon - Patient characteristics: gender, age, work status, marital status, level of education, years of CMC1 related symptoms.

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Countries

Netherlands

Outcome results